Latest FDA Warning Letters
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Advantage Biosciences, Inc. Newport Beach, CA (12/17/15). FDA reviewed the firm’s product labeling and its Web site at ww.resvantage.com Unapproved new animal drugs, adulterated. These products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs. For example, statements on the Web site make claims such as: Resvantage Canine: “Resveratrol can be used as a cancer therapy by itself or combined with other therapies.” For Resvantage Feline, it claims: “It helps support the immune system and has been shown to curb insulin resistance …” (Resvantage Canine, Feline, and Equine); FDCA 512(a), 501(a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479898.htm
ARB Medical, LLC Minnetonka, MN (12/22/15). Inspected 8/5-11/15. Violations: The firm failed to adequately validate, according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test. Critical product characteristics of the polypropylene and PTFE surgical meshes were not reviewed and approved before release, etc. (polymeric surgical meshes); FDCA 502(t)(2), 21 CFR 820.75(a), 820.30(d)&(g), 820.80(b), 820.198(a), 820.100(a), 803.50(a)(2), 803.17(a)(1), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480523.htm
Eclipse Aesthetics, LLC Dallas, TX (10/27/15). Unapproved device: FDA reviewed Web site http://eclipseaesthetics.com/ and learned that the firm is marketing TropoCells Autologous Platelet Preparation Kit under the proprietary name Eclipse PRPT. The device was cleared for marketing under premarket notification (510(k)) submission number BK110035 as a self-contained disposable kit containing two sterile blood separating vacuum tubes, two sleeve filters, various needles and a transferring device for the safe and rapid preparation of autologous platelet-rich plasma from a small sample of blood at the patient point of care. A video on the Web site makes claims such as: “How would you like to look ten to twenty years younger?” and “No need to go under the knife.” The information on the Web site is false or misleading. It lacks adequate descriptions of the risks, warnings, and contraindications of your product, etc. (Eclipse PRP); FDCA 501(f)(1)(B), 502(f)(1), 502(a), 502(o)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480331.htm
Edge Pharmacy Services, L.L.C Colchester, VT (11/12/15). Inspected the outsourcing facility 7/22-8/20/14. GMP deviations, adulterated, misbranded: The investigator noted that the firm failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 area in which sterile products are produced. Also, the investigator noted that some of the facility’s drug products do not include the following information on the label: a list of active and inactive ingredients, storage and handling instructions, and the statements, “This is a compounded drug” and “Not for Resale” and/or does not include information to facilitate adverse event reporting and a list of active and inactive ingredients (if there is no space on the label for such information) on the container. The facility failed to submit a report to FDA in 6/2014, and again in 12/2014, identifying the drug products that it compounded during the previous six-month period, etc. (drug products); FDCA 502(f)(1), 501(a)(2)(A)(B), 505(a), 21 CFR 211.113(b), 211.42(c)(10)(iv)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480583.htm
Hieber’s Pharmacy Pittsburgh, PA (9/29). GMP deviations, adulterated, misbranded: Domperidone is not the subject of an applicable USP or NF monograph, nor is it a component of an FDA-approved human drug product, and it does not appear on a list developed by the HHS secretary. The firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. It failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas, etc. (domperidone products); FDCA 501(a)(2)(B), 502(f)(1), 21 CFR 211.113(b), 211.167(a), 211.166(a), 211.42(c)(10)(iv)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480762.htm
Ionia Pharmacy, LLC Tustin, CA (12/22/15). Inspected 3/3/15-3/6/15. Violations, adulterated, unapproved new drugs: The firm does not monitor pressure differentials between the ISO 5 hood and the ISO 7 cleanroom. In addition, non-sterile wipes are used to disinfect the ISO 5 area, and items introduced to the ISO 5 hood from the ISO 7 area are not always disinfected appropriately, etc. (drug products); FDCA 501(a)(2)(A), 21 CFR 211.42(c)(10)(iv)(v), 211.28(a), 211.167(a), 211.166(a), 211.165(a),
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480560.htm
Irvine Stem Cell Treatment Center Newport Beach, CA (12/30/15). Inspected three firms: the Irvine Stem Cell Treatment Center 7/27-9/8/15, the Miami Stem Cell Treatment Center 7/27-9/11/15; and the Manhattan Regenerative Medicine Medical Group 7/27-9/19/15. CGMP and Current Good Tissue Practice deviations: The firm has failed to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms. It also failed to establish and maintain standard operating procedures describing the manufacturing equipment and the operating parameters used during the manufacturing process, etc. (firms recover and process adipose tissue, a structural tissue, from donors for autologous use); 21 CFR 1271.10(a), 1271.10(a)(2), 211.113(b), 211.165(b), 211.100(a), 211.160(b), 211.188, 211.80(a), 211.84(a), 211.42(c)(10)(iv), 211.198(a), 211.22(a), 211.67(b), 211.80(d), 1271.370, 1271.290(b)&(c)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479837.htm
Spoonamore Drug Co. Inc., dba Louisville Pharmacy and Custom Script Louisville, KY (12/18/15). Inspected 1/13-2/3/15. CGMP violations, unapproved new drug, adulterated, misbranded: The FDA investigator noted that drug products in the facility that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, where they may have become contaminated with filth or rendered injurious to health. The firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions, etc. (drug products); FDCA 502(f)(1), 501(a)(2)(B), 505(a), 21 CFR 211.42(c)(10)(iv)(v), 211.28(a)), 211.113(b)), 211.167(a), 211.165(a), 211.166(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480641.htm
Tibetan Herbal Balance, Inc. Malden, MA (1/4). Inspected 12/18/14-1/12. CGMP violations, unapproved new drugs, misbranded: Reviewed the firm’s Web site at http://www.tibetanherbs.com in 12/2015. It contains evidence of intended use in the form of personal testimonials recommending or describing the use of Liver Assist, Lung Support, and Respibalance for the cure, mitigation, treatment, or prevention of disease. The firm failed to establish specifications to sufficiently assure that the product it received for packaging or labeling as a dietary supplement is adequately identified and is consistent with its purchase order, etc. (Liver Assist, Lung Support, Respibalance); 21 CFR 111.70(f), 111.535(b)(2), 111.210(g), 111.15(i)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm479816.htm
Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City, China (12/31/15). GMP deviations, adulterated: FDA investigators discovered a lack of basic laboratory controls to prevent changes to the firm’s electronically stored data and paper records. It relied on incomplete records to evaluate the quality of its drugs and to determine whether they conformed with established specifications and standards. The firm routinely re-tested samples without justification and deleted analytical data. On 3/2/15 FDA observed that all 14 culture media plates in incubator #6 were dried out and cracked, which compromised microbial growth promotion and accurate enumeration. These plates were used to test multiple API batches of (purged). The firm’s investigation concluded that deformed glass plates caused the media to crack. In The company response, it claimed that the issue was isolated to the 14 culture media plates and that it retested these batches, but FDA says the response is inadequate because the investigation did not evaluate the (purged) other associated batches tested with culture media plates from the same lot containing deformed glass plates, etc. (active pharmaceutical ingredient); FDCA 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm480035.htm