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DNG Trading & Milling, LLC 10/21/14
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
October 21, 2014
VIA UNITED PARCEL SERVICE – Overnight Mail
Mr. David N. Gaon, CEO and Owner
DNG Trading & Milling, LLC
22 Brookville Road
Glen Head, NY 11545
Mr. James W. Mills, Executive Vice President
DNG Trading & Milling, LLC
4022 Mill Rd
Skaneateles, NY 13152-9319
Dear Messer's Gaon and Mills:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located in Skaneateles, New York from November 20, 2013 through December 12, 2013. Our investigation found that you have serious violations of FDA's Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you contract manufacture to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the CGMP regulation for dietary supplements. Further, several of your products are misbranded under Section 403 of the Act (21 U.S.C. §343). You may find the Act and its implementing regulations through links on FDA's home page at www.fda.gov.
Dietary Supplement Adulteration
On January 6, 2014 we received your response, dated January 3, 2014, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations issued to Mr. James W. Mills, Executive Vice President. We address the adequacy of this response below, in relation to each of the applicable violations. During our inspection of your facility, our investigator observed the following significant violations:
1. Your firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batches of your dietary supplements to ensure the quality of the dietary supplements, as required by 21 CFR 111.70(e). Specifically, you stated during the inspection that your firm does not have specifications established for the identity, purity, strength, and composition of your finished dietary supplements. For example, you have product specifications for the finished (b)(4) dietary supplement you manufacture; but these specifications include only physical specifications (for appearance, extraneous material, color, moisture, and product weight), microbiological specifications (for total plate count, total coliform, yeast, mold, Enterobacteriaceae, Pseudomonas aeruginasa, Staphylococcus aureus, E. coli, and Salmonella), and contaminant specifications (for arsenic, cadmium, lead, and mercury). These finished product specifications are inadequate because even if met, these specifications would not ensure the identity, purity, strength and composition of the product.
We received your response dated January 3, 2014, and found it to be inadequate. Although you state that product specifications for the identity, purity, strength, and composition of the finished dietary supplements you manufacture have been developed, you have not provided any supporting documented evidence of established finished product specifications for identity, purity, strength, and composition of the finished dietary supplements.
2. You failed to conduct at least one appropriate, scientifically valid test or examination to verify the identity of a component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i) and 111.75(h)(1). Specifically, your firm has not conducted appropriate, scientifically valid tests to verify the identity of any of the dietary ingredients used in the manufacturing of dietary supplements by your firm.
For example, your (b)(4) contain the dietary ingredient Tribulus Terrestris. However, your Raw Material Specifications sheet for this product only requires the visual inspection of the color of the received powder to confirm the identity of the ingredient. This ingredient, which is a powder, cannot be identified through organoleptic testing. There is no ability to distinguish this ingredient from other powder ingredients through gross organoleptic analysis. Moreover, while color is an intrinsic property of an article, it is not exclusive to the article: many articles (or compounds) have the same color. Furthermore, a food color may be added to the article. Therefore, while an incoming dietary ingredient of the wrong color could be excluded, an article of the same color is not substantiation of the identity, because as stated, many articles have the same color. Moreover, an article could have the same color and still be rejected, if, for example, its spectroscopic data were not identical to a reference standard. Color cannot, therefore, be used as positive evidence of identity.
We received your response dated January 3, 2014, and found it to be inadequate. You state that identity testing of dietary ingredients is being performed on an as-needed basis prior to use in any dietary supplement products. "As needed" is not an adequate basis for identity testing. Furthermore, you have not addressed the appropriateness of your testing methods, nor have you provided any supporting documentation.
3. Your master manufacturing records (MMR) fail to meet the requirements of 21 CFR 111.210. Specifically, the records fail to contain:
a. A statement of the expected minimum and maximum percentages of the theoretical yield of the finished dietary supplement beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)];
b. A representative label, or a cross reference to the physical location of the actual or representative label [21 CFR 111.210(g)]; and,
c. Procedures for sampling [21 CFR 111.210(h)(2)].
Your MMR for your (b)(4) did not include minimum or maximum percentages of the theoretical yield beyond which a deviation investigation is necessary, nor did it include procedures for sampling. Your MMR for this product did include a label; however, the label was outdated and therefore not representative of the product labels at the time of manufacture.
We received your response dated January 3, 2014, and found it to be inadequate. Although you state that your MMRs have been changed to address these issues, you have not provided any supporting documentation, such as revised MMRs. We acknowledge receipt of your updated procedures regarding labeling controls and sampling procedures (SOP-QAM-008, SOP-QAM-003A, and SOP-WAR-003).
4. Your operations for the batch production records failed to include reviewing and approving all batch production-related records as required by 21 CFR 111.123(a)(2). Specifically, your Quality Assurance Manager did not adequately review and approve all batch production records for your (b)(4) batches. For instance, the Formulation Batch Sheet, Batch Report, and Pre-Operational Encapsulation Check-sheet were not reviewed and signed by Quality Assurance after your firm conducted the relevant operations.
We received your response dated January 3, 2014, and found it to be inadequate. Although you have revised your procedure, SOP-QAM-011, and have provided this procedure for review, your firm did not provide evidence of how you are implementing these revised procedures, such as current batch records.
5. You failed to perform each step in the appropriate MMR on the production of each batch, as required by 21 CFR 111.255(c). Specifically, your MMR for (b)(4) requires a ≥ 40 minute blend time; your batch production record (BPR) for Lot (b)(4) reveals that the product was only blended for what appears to be 24 minutes.
We received your response dated January 3, 2014, and found it to be inadequate. Although you have revised your procedure, SOP-QAM-011, and have provided this procedure for review, your firm did not provide evidence of how you are implementing these revised procedures, such as current batch records.
Dietary Supplement Misbranding
1. Your (b)(4) and (b)(4) products are misbranded under Section 403(w) of the Act, [21 U.S.C.§ 343(w)], in that the finished product label fails to declare the known major allergen, milk, as specified in the Act.
Section 201 (qq) of the Act [21 U.S.C.§ 321 (qq)], defines "major food allergens" as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing protein derived from one of these foods, with certain exceptions, e.g., highly refined oils derived from a major food allergen. A food is misbranded under section 403 (w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
- The word "contains", followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients, Section 403(w)(1)(A) of the Act [21 U.S.C. §343(w)(l)(A)]; or
- The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "Whey (Milk)"), except the name of the food source is not required when whether the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), Section 403(w)(1)(B) of the Act [21 U.S. C. §343(w)(l)(B)}.
Specifically, your (b)(4) label lists the ingredients: L-arginine, Ying Yang Hou, Chen PI, Chn, Yao, Renshen, Catauaba, Muira Puama, Rou Cong Dong, Wu Wei Zi, BioPerine®. However, the batch production records for
(b)(4) reveal it contains Whey Protein Concentrate 34% (a dairy allergen).
Specifically, the (b)(4) label lists the ingredients: Senna Leaf, Capsicum, Plantain Leaf, Xanthan Gum, Kelp, Gingko Leaf, Echinacea Purpurea Tops, Bromelain, Garlic Bulb, Ginger Root, Ginseng, Mate, Meadowsweet, St. John's Wort, and Valerian Root. However, the batch production record for (b)(4) reveals it contains Whey Protein Concentrate 34% (a dairy allergen).
2. Your (b)(4) products are misbranded within the meaning of Section 403(e)(l) of the Act [21 U.S.C. §343(e)(l)] because they fail to list the place of business of the manufacturer, packer or distributor in accordance with 21 CFR 101.5.
3. Your (b)(4) products are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S. C.§ 343 (i)(2)] in that they are fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.36 and 21 CFR 101.4. Specifically, your (b)(4) product label does not accurately contain the ingredients listed on the batch production record and doesn't list capsule ingredients.
4. Your (b)(4) products are misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C.§343(q)(5)(F)] because the label fails to bear nutrition labeling in the proper format, which is required under 21 CFR 101.36. For example, the nutrition information on your (b)(4) product lists ingredients in the wrong order in accordance with 21 CFR 101.36(b)(2)(i)(B).
5. Your (b)(4) products are misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 US.C. § 343 (s)(2)(B)] in that the label fails to identify the products using the term dietary supplement, in accordance with 21 CFR 101.3(g).
6. Your (b)(4) product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 403 (q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined by 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example the product label states a serving size of 1 capsule; however, the suggested usage states take 1 or 2 capsules 30 minutes before breakfast, lunch, and dinner with an eight ounce glass of water per capsule.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent the Food and Drug Administration; Attention:
LCDR Frank Verni, R.Ph.
Compliance Officer
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
If you have any questions about the content of this letter please contact: LCDR Verni at (718) 662-5702.
Ronald M. Pace
District Director
New York District


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88 W. Highway 4
Murphys, CA
Murphys Music Company is a full service music store that features one of the best collections of ukulele and ukulele accessories on the planet. At Murphys Music Company we enjoy supplying you with the instruments and supplies you need to play your best. We are interested in starting new musicians, teaching you the instrument you want to learn, helping you progress and grow, or in helping you find the right music teacher.

subset: commoncrawl


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When will the post-op weight fall off? (Photo)
Doctor Answers 3
Sudden weight increase after surgery
Thank you for your question!
Implants by themselves may add to your weight by 1-2 lbs, but not 7 pounds. The rest is probably retention of body water. So if there is inflammation, swelling, and if large amounts of local anesthetics or intravenous fluids were used, then the weight would be higher. But this is temporary. Also check the weighing scale you used as it may not be calibrated correctly.
Also, please rest assured that feeling depressed within the first week after surgery is a common feeling among patients, so you are not alone.
The 1st few weeks after a cosmetic surgery such as breast augmentation can be difficult both physically and emotionally. Post-operative depression is real, and its effects can be minimized if patients are prepared for and understand it in advance.
During the first week, there will be swelling, pain, discomfort, and physical change. This is a time when your inner and outer energy level will be low making you disinterested in other things. Pain medications will make you disoriented and emotional with feelings of depression coming about the 3rd or 4th day. You will start to feel better with the stitches out, and the decrease in swelling and muscle cramps.
Depression may set in due to perception of body image – and in your case, increase in perceived weight. Additionally, traces of anesthetics used to make you sleep during surgery can temporarily stay in your body's tissues affecting you both physically (fatigue and exhausted) and emotionally (depressed and in despair) for up to 3 weeks. In addition to reducing your pain, your use of narcotic pain killers which are also considered depressants also slow everything down like alcohol bringing out a range of emotional reactions based on the mood and atmosphere of their surroundings.
The final addition to this is the physical restrictions inherent in recovery. Your usual routine in life will be dictated by the instructions for recovery which limit your movements by many weeks to allow healing. For example, you will not be able to fully use your chest muscles for a couple of weeks limiting your ability to drive, pick up things that are more than 10 pounds, change clothes, etc. Because of this loss of control of your body, your looks, your schedule, you will be stuck in bed, depending on others with basic tasks such as self-care and other daily-activities minimizing your level of independence. Because of being out of your comfort zone, you may experience feelings of restlessness, helplessness, hopelessness, and boredom. Due to the lack of exercise, your brain will only provide a short supply of endorphins.
If you maintain your diet, you should not be gaining any pounds other than the first few weeks due to inactivity. As such, try to eat healthy, fresh, and nutritious meals/snacks to aid the healing process such as more fruits and vegetables. You will want to get lost of rest.
You should always follow your surgeon's instructions for recovery. Please share your feelings and concerns with your plastic surgeon as they will be in the position to best help you with not only you physical concerns, but your mental and emotional concerns.
Best of luck in your recovery!
Try not to worry
The weight gain you are experiencing is likely from the intravenous fluid that was given to you during surgery. Over the course of the next 2- 3 weeks your body will get rid of that fluid. A very small portion of that weight gain will be from the weight of the implants, but that is only a very small amount. As far as breast size is concerned, I tell my patients that it takes 3 months for all the swelling in the breast to disappear. At this time you will have a better idea of the new size of your breast. Your breast size will not change significantly.
Best wishes,
Dr. Ravi Somayazula
Learn more: http://www.bodybyravi.com/gallery/breast/breast-augmentation/
Post op weight
First of all, the implants probably weigh about two pounds. A 450cc implant is approximately one pound. You are still swollen and your body wants to hold on to fluid after surgery. Be patient, don't worry and give it 6-8 weeks to totally resolve. Jane
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These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.


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Selling manga and other anime-related things to pay for bird-care and food.
June/DMP Manga $9 each
All manga are in new/like new condition
Alcohol, Shirt, & Kiss
Can't Win With You! Volume 1
Don't Say Any More Darling
Flower of Life Volume 1
Jazz Volumes 1-3
La Esperanca Volume 1
Little Butterfly Volumes 1 & 3
Manic Love
Star (We have two of these)
Sweet Revolution
Vanilla Volume 1
Yellow Volume 4
Misc Yaoi Manga $7 each
All manga are in like new condition unless otherwise noted!
FAKE Volumes 1-5 (the cover of volume 4 is all bent up. I'll sell this one for $5)
Gakuen Heaven (corner of back cover bent)
Lovers in the Night
Skyscrapers of Oz
Until the Full Moon Volumes 1 & 2 (complete)
Non-Yaoi Manga $7 each
All manga are in like new condition unless otherwise noted!
.hack//Legend of the Twilight Volume 2
Big O Volumes 1 & 2
Cowboy Bebop Volume 1
Deathnote Volumes 2 & 4 (Perfect condition, $6 each)
Excel Saga Volume 1
G Gundam Volume 1
God Child Volume 1 (Dents in front cover, $5)
Lupid III Volume ??? (Japanese, back cover has some dirt, $4)
Maho Romantic Volume 3 (Back cover at a curve, some bends, $6)
Neon Genesis Evangelion Volume 1 (The really old Viz edition!)
One Piece Volume 1 (SJ Manga, $6)
Ragnarok Volume 1
R.O.D. (Read or Die) Volume 1 (Back cover corner bent, $6)
Revolutionary Girl Utena Volumes 1 & 2 (Viz run)
S-Cry-Ed Volumes 1 & 2
Wolf's Rain Volume 1 (Viz run)
All manga ships for $3, but if you order 3 I'll ship it for free!
Paypal only!
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Assistant Professor
Computer Science Department
Carnegie Mellon University
I am an Assistant Professor in the Computer Science Department at Carnegie Mellon University. I am a member of the Principles of Programming group and affiliated with the Pure and Applied Logic program. I also have an affiliate appointment in CMU's Computational Biology Department.
I received my PhD from MIT in 2015 and my bachelor's degree from Harvard in 2008. During the 2015-2016 academic year I visited the Fontana Lab at Harvard Medical School.
Along with new faculty members Matt Fredrikson and Jan Hoffmann, I am actively looking for PhD students. You may read more about my research plans here.
More and more people are programming: not only those with traditional Computer Science backgrounds, but also physical scientists, journalists, and more. We have an unprecedented opportunity to shape how people reason about software--and the systems that people do not yet call software. The goal of my research is to make provable guarantees ubiquitous. I am interested in designing programming models, language implementation strategies, and programming tools to make it easier for people to create the software they intended. Application domains of interest include security, privacy, and biological modeling.
Public understanding and consumption determine the impact of research. Because of this, I am interested in improving science communication and facilitating commercialization of technical ideas. From 2013-2015 I co-directed NeuWrite Boston, a working group of scientists and science writers. To narrow the gap between academia and industry, I co-founded the Cybersecurity Factory, an accelerator for security startups, with Frank Wang.
|I have staged an accidental coup of the Principles of Programming Languages (POPL) 2018 conference. I am a Program Committee member, the Publicity Chair, and the Artifact Evaluation Co-Chair (along with Catalin Hritcu). Submit to POPL!
|I am Program Co-Chair for the Static Analysis for Systems Biology (SASB) 2017 workshop, with John Bachman from Harvard Medical School. We encourage you to submit!
|I co-designed and co-taught 15-316: Software Foundations of Security and Privacy with Matt Fredrikson spring 2017.
|The MIT Technology Review featured me as one of their "35 Innovators Under 35." Profile here.
Technology is a powerful social tool. Astra Taylor writes that "programmers and the corporate officers who employ them are the new urban planners, shaping the virtual frontier into the spaces we occupy." Everyone, regardless of their background, should have the opportunity to contribute to shaping this frontier.
Towards this, I started Graduate Women at MIT during my PhD and am generally interested in encouraging more women and underrepresented groups to pursue technology as a career.
Also interested in creating more positive, supportive workplace environments, I started the Positivity@MIT project.
It is now fashionable to have such a section on one's website.


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Our full-service design/build process encompasses all aspects of your project from concept to construction. Our design services include: consultations, site reviews, topography, complete schematic drawings, design specifications, and proposals. Our construction services include: pre-construction meetings, project management, scheduling, on-site crew managers, landscape construction, and walkthroughs. Our team of experienced project managers oversee every detail of your project through both design and construction, tightening up communication and ensuring a smooth process.
Initial Design No-Charge Consultation & Design Agreement
Meet with a licensed landscape architect in your home to discuss your landscaping goals. If the initial consultation meets your expectations, you will be given a quote. A design deposit of 50% is required to move forward.
Site Survey & Preliminary Design
Each design begins with a site survey for our landscape architects to work from. Then, we flesh out a first draft in-house with construction in mind. A schematic landscape design based upon the initial consultation will be presented.
Design Refinements & Construction Proposal
After the preliminary design presentation, revisions to the design are made, if necessary, based on your feedback. A second meeting will include a review of the revised design and a written estimate for the services to complete the proposed landscaping. Final revisions can be made at this time or during additional meetings.
Contract Signing & Project Coordination
At this time a contract for services may be signed, a one-third deposit is made to reserve your spot in our construction schedule, and we will break ground on your new backyard resort per the construction schedule. Depending on your location's climate, construction can take place year round. Progress payments are made throughout the construction process. The remainder of the balance is due upon completion.
Construction, Project Management & Plantings
With a single point of contact for the entirety of your project, you'll become lost in the creative process, not paperwork. With no crews to coordinate or phone calls to line up, you'll be free to explore the possibilities of your ideal backyard resort. Our multi-disciplinary team offers a diverse, up-to-date skill set to meet our clients' dynamic needs. On the off-chance that we need external support, we have decades-long relationships with several talented and respected subcontractors who will only be tapped as the need arises.
Project Completion Walkthrough & Warranty
Once construction is completed, a final review will be conducted to ensure your happiness with the end result. Your satisfaction is backed by our warranty. The remainder of the balance is due upon completion of the project.
We walk you through the process from design to finished construction. With our multi-disciplinary team of licensed Seattle landscape designers, project managers, and licensed contractors on your side, creating your dream backyard will almost be as easy as enjoying it.
We had a fantastic experience working with Alderwood Landscaping on a complete overhaul and redesign of our backyard. We started by working with Tim, a landscape architect, who helped us figure out exactly what we wanted in our backyard. He answered all of our questions, met with us on multiple occasions and reworked plans/drawings until they were just right. We absolutely love how our backyard turned out! It is beautiful, functional and comfortable. It is so much more than we had hoped for or expected when we started the project.
– The Sanders