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.
Apotheca Supply, Inc. dba Apothecares Decatur, AL (4/7). Inspected 2/10-12/15. CGMP deviations, adulterated: The firm’s quality unit failed to review and approve all quality related documents and its main responsibilities were not described in writing. The firm also failed to have stability data to support the extension of expiration dates. It extended API manufacturers’ expiration dates by as much as two years and listed the new expiration dates in its CoAs for APIs repackaged at the firm’s facility. This deviation is similar to one found during a 1/2010 inspection. The firm weighs and repackages bulk powder APIs including hormones, tricyclics, muscle relaxants, NSAIDS, antifungals and quinolones in non-dedicated suites using non-dedicated equipment, etc. (pharmaceuticals); FDCA 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm496462.htm
Crescent Health Center, Inc. Irvine, CA (4/20). Inspected 11/18-12/2/15. FDA reviewed Web sites at www.skinbeautymall.com, www.agelessderma.com, and www.drskinspa.com in February. Misbranded: The products are promoted for uses that cause them to be drugs. For example, the label states, “Ageless Derma brand Stem Cell and Peptide Anti-Wrinkle”: “[I]mproves the firmness and elasticity of skin, removes crow’s feet…” (Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream and Ageless Derma Anti-Aging Intensive Skin Brightener Cream); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497702.htm
Grams Medical Products Costa Mesa, CA (3/17). Inspected 9/14-25/15. QSR deviations, adulterated: The firm has not validated a cleaning and sterilization process for the reusable cannula tips used in conjunction with the Grams Aspirator S-300. These tips are stored, unwrapped in open wooden bins in a packaging and shipping room. No baseline bioburden has been established for these cannula tips, no studies have been performed to ensure specific sterilization processes will not adversely affect these tips, etc. The firm also failed to adequately maintain a device master record or establish procedures for device history records, etc. (Grams Aspirator S-300); FDCA 501(h), 502(t)(2), 21 CFR 820.75(a), 820.181, 820.184, 820.20(c), 820.22, 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497792.htm
Hartley Medical Center Pharmacy, Inc. Long Beach, CA (4/21). Inspected 6/29-7/8/15. CGMP violations, adulterated, misbranded: FDA investigators noted the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. Also the investigators observed serious deficiencies in its practices for producing sterile drug products. For example, the firm produced sterile (purged) from non-sterile components and then stored them in (purged) containers, which were subsequently punctured multiple times throughout the assigned expiry period, which, according to FDA, compromises the integrity of the container closure system and increases the chances of contamination with each puncture. The firm’s proposed corrective action is not adequate to demonstrate container closure integrity. Also it does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, etc. (drug products); FDCA 501(a)(2)(A)&(B), 502(f)(1), 505, 211.42(c)(10)(iv)(v), 211.167(a), 211.28(a), 211.113(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm498592.htm
Oeyama-Moto-Medical Group Foundation, LLC West Covina, CA (3/29). Inspected 8/11-9/29/15. Clinical investigator violations: The group violated a clinical hold by allowing a clinical investigator to give subjects an investigational drug after FDA issued an order to delay a proposed investigation. The group failed to ensure proper monitoring of the clinical investigations. Its response to FDA indicated that it monitored the progress of the study through its IRB and documented this in the IRB meeting minutes. FDA says this is inadequate because an IRB cannot assume the sponsor’s responsibility to ensure proper monitoring of clinical investigations. (investigational drug study); 21 CFR 312.42(a)&(b), 312.50, 312.56(a), 312.52
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497595.htm
Pacific Nutritionals, Inc. Vancouver, WA (4/15). Inspected 11/9-23/15. CGMP violations, unapproved new drugs, adulterated dietary supplements: The firm failed to establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements. The investigator observed that system suitability for the firm’s HPLC equipment was not performed per its approved procedure. Also, the firm failed to calibrate instruments or controls used in manufacturing or testing a component or dietary supplement to ensure the accuracy and precision of the instruments or controls, etc. (supplements including multivitamin, Ashwagandha); FDCA 403(y), 403(s)(2)(B), 403(q)(1)(A), 21 CFR 111.70(c)(1), 111.73, 111.70(e), 111.75(c), 111.75(h)(1), 111.95(b), 111.105(a), 111.315(d), 111.27(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497840.htm