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.
American Pure Whey, LLC Raleigh, NC (5/24). Inspected New Bern, NC facility 9/15-18/15. CGMP deviations, adulterated, misbranded: The American Pure Whey 100% Pure Whey Matrix Chocolate includes directions for use for the product “[a]s a dietary supplement,” but the product is not properly labeled as a dietary supplement. Based on FDA’s observations during the inspection, if this product were a dietary supplement, it and any other dietary supplements the firm manufactures would be adulterated within the meaning because they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. For example, the firm failed to establish and follow written procedures for the responsibilities of the quality control operations. Also, it does not make or keep batch records for any of its dietary supplement products. Following the inspection, a sample of the American Pure Whey 100% Whey Protein Matrix Chocolate product was submitted to the Southeast Regional Laboratory to be analyzed for protein and sugar content. The label for this product states that it provides 26 grams of protein per serving, but the analysis found differently, etc. (American Pure Whey 100% Pure Whey Matrix Chocolate); FDCA 402(g)(1), 403(a)(1), 403(w), 403(i)(2), 403(s)(2)(B), 403(y), 403(q)(5)(F), 21 CFR 111.103, 111.105, 111.205(a), 111.70(a)&(b)&(c)&(e), 111.95(b)(1), 111.260, 111.410(c), 111.83(a), 111.360, 111.403, 111.430(b), 111.503, 111.553
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506386.htm
Berwickshire Electronic Manufacturing Ltd. Duns, United Kingdom (2/4). Inspected 11/11-11/13/15. QSR deviations, adulterated: The firm has not established production and process control procedures that include: monitoring and control of process parameters, components, and device characteristics during production. The firm failed to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, etc. (Helica Thermal Coagulator and the Helica LT/LTC Probes); FDCA 501(h), 502(o), 21 CFR 820.70(a), 820.90(a), 820.50, 820.80(b)&(d), 820.72(a), 820.100(a), 820.200(a), 820.181
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506423.htm
Millers of Wyckoff, Inc. Wyckoff, NJ (6/7). Inspected 6/29-7/16/15. GMP deviations, adulterated, misbranded: FDA investigators noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. Investigators observed an operator that failed to disinfect materials prior to introducing them into the ISO 5 area and an operator that re-used a laboratory coat that fell on the floor. Also, the firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions, etc. (sterile drug products); FDCA 501(a)(2)(B), 502(f)(1), 501(a)(2)(A), 21 CFR 211.113(b), 211.28(a), 211.42(b)&(c)(10)(v), 211.167(a), 211.166(a), 211.192
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506331.htm
Neuralight HD, LLC Phoenix, AZ (4/14). Inspected 5/11-20/15. The firm failed to submit an IND for the conduct of clinical investigations with an investigational new drug. The investigational drug was not a lawfully marketed drug product in the United States and therefore was not exempt from the IND requirements, etc. (investigational drug study); FDCA 355(i), 312.2(a), (b), and 312.40(a) and (b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm507547.htm
S.R. Burzynski Manufacturing Facility Stafford, TX (6/13). GMP deviations, adulterated: 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. The poor facility and equipment design inadequately protects the sterile (purged) product during manual manipulations, poses a substantial hazard to product sterility, and presents an unreasonable risk to patient safety. During a demonstration of cleaning and disinfection practices for the aseptic processing room, FDA investigators observed an operator who wore eye makeup with no eye protection. The operators wore clothing that allowed for exposed skin on their faces and necks. Also, personnel reused these suits on multiple aseptic processing production days, with no cleaning or sterilization between uses, etc. (drug products); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.42(c)(10), 211.28(a), 211.84(d)(6)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm507554.htm
Qualgen, LLC Scottsdale, AZ (6/3). Inspected Edmond, OK facility 8/24/15-9/17/15. CGMP deviations, adulterated, unapproved new drugs, misbranded: The investigators observed that the ceiling tiles of the firm’s ISO 7 cleanrooms were not fully sealed, allowing ingress of unfiltered air from the surrounding non-classified area. Also, the process used to render the implantable hormone pellets sterile is not adequate as evidenced by the multiple sterility failures. The investigators also noted that the company failed to perform adequate investigations into these sterility failures, etc. (drug products); FDCA 502(f)(1), 501(a)(2)(A)&(B), 21 CFR 211.113(b), 211.42(a), 211.192, 211.166(a), 211.22(c), 211.100(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506829.htm
Tyrx, Inc. Monmouth Junction, NJ (6/2) Inspected 11/30/15-2/12. QSR deviations: A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. The firm failed to establish procedures for the control and action to be taken on devices distributed, and those not yet distributed, that are suspected of having potential nonconformities. 21 CFR 820.70(b), 820.75
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm506502.htm