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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.

Gentell Inc. Bristol, PA (10/5). Inspected 7/29-8/25. QSR deviations, adulterated: The firm has not sufficiently demonstrated that appropriate personnel with the necessary education and training are given the authority to assess the quality of medical devices (e.g., gauze, gel and wound dressings) made and/or distributed by the facility. Also, the firm failed to establish procedures for corrective and preventive action. For example, SOPs were provided during the inspection, but there was no SOP that addressed an established CAPA system included in the records. The firm’s management has not established an approved device master record for manufacturing (purged) wound dressings and there is no evidence of approved specifications for equipment, production methods, components, production environment, formulations, packaging and labeling, etc. (wound dressings and gauzes); FDCA 501(h), 21 CFR 820.20, 820.100(a), 820.198(a), 820.75(a), 820.181, 820.184, 820.25(a)

St. Jude Medical St. Paul, MN (9/30). GMP deviations, adulterated: The firm has not maintained an effective CAPA system at its Atlanta, GA facility and has not adequately investigated known problems identified through customer complaints, non-conformances, and other sources in accordance with its established CAPA procedures. For example, the investigation for CAPA 14-004 (issued 11/5/2014 for defects found in coated sensors, i.e., a lack of adhesion uniformity, coating imperfections, and fractured glass) was due on 12/5/2014, but it the CAPA investigation is currently outstanding. Process validation activities have not been documented and approved. Procedures for quality audits have not been adequately established, etc. (Cardiomems HF System); FDCA 501(h), 21 CFR 820.100(b), 820.75(a), 820.70(a), 820.22


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