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.
Cape Apothecary, Inc. Annapolis, MD (8/12). Unapproved new drugs, adulterated, misbranded: The drug products that the firm manufactures and distributes without valid prescriptions for individually-identified patients are not the subject of approved applications. Compounded drug products containing domperidone are not eligible for the exemptions under section FDCA 503A because domperidone is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on a list developed by the HHS secretary. The drug products that are intended or expected to be sterile were prepared, packed, or held under unsanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. Investigators noted that the firm did not use a sporicidal agent and used non-sterile sanitizers in the aseptic processing area. Also, operators were observed placing materials and components into the ISO 5 hood with their ungloved hand, etc. (drug products); FDCA 501(a)(2)(A)&(B), 502(f)(1), 505(a), 21 CFR 211.42(c)(10)(vi)(v), 211.113 (b), 211.166(a), 211.167(a), 211.28(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516594.htm
College Pharmacy Colorado Springs, CO (8/15). Inspected 5/11-28/15. CGMP deviations, adulterated, misbranded: Investigators noted that the facility was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. The firm uses unlicensed materials (rather than FDA-licensed allergenic extracts and appropriate diluents) in manufacturing certain allergenic products, which is outside the scope of an approved biologics license application. It also failed to validate the procedures used in its aseptic and sterilization operations, etc. (sterile drug products and allergenic products); FDCA 501(a)(2)(A)(B), 502(f)(1), 505(a), 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)(iv)(v), 211.28(a), 211.84(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516912.htm
Frontida BioPharm, Inc. Exton, PA (8/15). CGMP deviations, adulterated: Significant findings indicate that the quality unit is not fully exercising its authority and responsibilities. The quality unit knowingly released 27 lots of various strengths of clonidine HCl tablets on or about 3/5/15, despite evidence that active pharmaceutical ingredient used in their manufacture was potentially contaminated. Also, FDA found found multiple discrepancies in quality unit-approved records, such as: investigation reports containing data and documentation from unrelated investigations; records signed with only a first name; records missing dates; and illegible entries in logbooks and laboratory notebooks, etc. (drug products); FDCA 501(a)(2)(B), 21 CFR 211.22(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516918.htm
Huzhou Aupower Sanitary Commodity Co., Ltd. Huzhou City, Zhejiang, China (8/10). Inspected 9/14-18/15. GMP deviations, adulterated: The firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. It failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. It also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced, etc. (drugs); FDCA 501(a)(2)(B), 21 CFR 211.165(a), 211.166(a), 211.100(a), 211.188
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516836.htm
Tosoh Bioscience, Inc. San Francisco, CA (8/5). Inspected Grove City, OH 5/16-6/28. QSR deviations, adulterated: The firm failed to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications. It also failed to establish and maintain adequate procedures for implementing corrective and preventive action that shall include requirements for analyzing processes, work operations, concessions, audit reports, quality reports, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming products, or other quality problems. The response is not adequate in that the firm states that it is revising its procedures, but it does not address performing a retrospective analysis of all data sources to determine if corrective action and preventive action should be opened and investigations of existing and potential causes of nonconforming product and other quality problems will be initiated, etc. (repacker/relabeler of high performance liquid chromatographs used in measuring hemoglobin, automated immunoassay analyzers used in treating disease, and laboratory solutions, assays, test-cup reagents, and hemolysis and wash solution used with the HPLC devices); FDCA 501(h), 21 CFR 820.198(c), 820.100(a)(1), 820.100(4), 820.50, 820.70(g)(1), 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516914.htm
Unimark Remedies Ltd. Mumbai, India (8/12). Inspected 5/18-22/15. CGMP deviations, adulterated: At the Vapi facility, the firm failed to adequately investigate and document out-of-specification results and implement appropriate corrective actions. The firm did not place samples from any of the batches produced through modified processes in its stability monitoring program to assess the effects of these changes on the quality of its API throughout the expiry period. At the Bavla facility: The firm routinely re-tested samples without documented justification and deleted analytical data. FDA’s inspection found that it did not adequately investigate failing or atypical results, etc. (drugs); FDCA 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516883.htm