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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.

Biocompatibles, Inc. Oxford, CT (4/30). Inspected 2/26-4/3. QSR deviations, adulterated: The firm failed to validate the process for fitting prostate needles with a bioabsorbable polymer plug to ensure that the amount of force required to push out the plug during actual conditions of use consistently meets appropriate, validated specifications. It also failed to record all test data associated with prostate needle lots which were used in patient-specific radioactive brachytherapy needle sets. The firm failed to adequately investigate a complaint dated 8/23/12 involving the patient-specific radioactive brachytherapy needle sets The complaint states that three different oncologists were finding it difficult to push the plug out of the prostate needles resulting in three patients receiving radioactive seeds in their bladder which were meant for their prostate. No risk assessment or health hazard evaluation was conducted nor were any corrective actions initiated, etc. (patient-specific radioactive brachytherapy needle sets); FDCA 501(h), 21 CFR 820.75(a), 820.100(a)(1), 820.198(c), 820.70(c)

Care Diagnostica GmbH Moellersdorf, Austria (4/23). QSR deviations, adulterated: The firm has not established and documented CAPA procedures to ensure that quality problems are adequately investigated. It also failed to maintain records of changes to documents and failed to establish and maintain procedure to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, etc. (IVD Test Kits); FDCA 501(h), 21 CFR 820.100(a), 820.70(g), 820.40(b), 820.250(b)

CMI Cosmetic Manufacturers Inc. Concord, Ontario, Canada (4/25). Inspected 10/22-24/12. GMP deviations, adulterated: The firm failed to conduct identity tests of incoming raw materials. It accepts and relies upon the suppliers’ Certificates of Analysis for drug components without conducting adequate vendor qualification. It failed to evaluate the effectiveness of its cleaning procedures and does not have data to show that the equipment cleaning procedure is adequate to prevent cross-contamination, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 510(i)(1), 21 CFR 211.84(a), 211.67(b), 211.186(a)

EuroPharma Co., Inc. Green Bay, WI (4/24). Reviewed Web site at www.europharmausa.com in February. Claims made on the site include: “Curcumin [an ingredient in Mental Advantage] has been shown to bind to plaque-forming beta-amyloid,” and “Ravensara oil taken internally as a chemotyped plant oil is one of my top recommendations for treating all types of bacterial, viral, or fungal illnesses – from common colds and the flu to yeast overgrowth, pneumonia, ear infections, sinus infections, and more.” Labeling fails to bear adequate directions for their intended uses, causing the products to be misbranded, etc. (Calm Kids, CholestCaps, CuraMed 375 mg, CuraMed 750 mg, Curamin, Mental Advantage, Tri-Iodine, and Viragen); FDCA 505(a), 502(f)(1)

GRI Medical & Electronic Technology Co., Ltd. Jiaxing, Zhejiang, China (5/1). Inspected 12/17-20/12. QSR deviations, adulterated: The firm’s Corrective and Preventive Action (CAPA) Procedure is incomplete in that the firm has yet to establish requirements/criteria/limits that would trigger a CAPA based on factors such as data analysis of complaints, process rejects, or supplier performance. 2012 CAPAS were not based on data analysis. Several nonconforming products were observed in various red bins without identification documentation as required by the firm’s Non-Conforming Product Control Procedure, etc. (sterile and non-sterile products: surgical gowns, surgical drapes, ophthalmic patient drapes, compressible limb sleeves, I.V. containers, light handle covers, blood lancets, specimen containers, etc.); FDCA 501(h), 21 CFR 820.100(a), 820.90(a), 820.70(a), 820.250(b), 820.120(d), 820.22, 820.184

Natus Europe GmbH Planegg, Germany (4/19). Inspected 11/12-15/12. Misbranded: The firm failed to develop, maintain, and implement written MDR procedures. There is no evidence that the firm’s MDR procedure has been implemented in that there is no effective date for the procedure. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, etc. (Echo Screen devices); FDCA 502(t)(2), 21 CFR 803.17, 803.50(b)

Olympia Women’s Health Olympia, WA (4/24). Inspected 2/25-3/1. The firm failed to determine as ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent. It also failed to test a specimen from an anonymous or directed reproductive donor of cells and tissue, whether viable or non-viable, for evidence of infection due to relevant communicable disease agents. There is no documentation of which donor screening tests are used by the firm’s contract testing laboratory for donor testing for relevant communicable diseases or that the test kits are FDA-licensed, approved, or cleared donor screening tests, etc. (human cells, tissues, and cellular and tissue-based products); 21 CFR 1271.85, 1271.80(c), 1271.80 and 1271.85, 1271.3, 1271.50(a), 1271.55(a)(1), 1271.45-1271.90, 1271.80, 1271.85, 1271.50

Pristine Bay, LLC dba Vianda Cincinnati, OH (4/26). Inspected 8/28-9/17/12. CGMP violations, adulterated: The firm failed to establish finished product specifications for the identity, purity, strength, and composition of its finished dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplements to ensure quality. The firm provided some written procedures for quality control operations, but the warehouse manager stated that the firm has not been following such procedures since the quality control manager left the firm in 7/2011, etc. (Enzyte, Ogoplex, and Avlimil Complete); 21 CFR 111.70 (a) and (e), 111.65