Recent Warning Letters - Pharmaceutical & Medical Device Regulatory Update, Vol. II, Issue 4

Since we last reported on enforcement actions in January 2015, FDA posted warning letters to drug and device manufacturers for violations related to CGMP ("Current Good Manufacturing Practices"), QSR ("Quality Systems Regulations"), and MDR ("Medical Device Reporting"). The amount of warning letters declined compared to when we last reported in January 2015, with only four warning letters sent to medical device manufacturers and three to drug manufacturers since our last Update. 

FDA continues to cite medical device manufacturers for CGMP and QSR violations, including those related to device designs, maintaining device master records, complaint procedures, post-sterilization inspections, and device packaging and shipping containers. Recipients of these warning letters included manufacturers of in vitro diagnostic devices, intravenous tubing sets, and convenience packs for surgical procedures. One medical device manufacturer was also warned for failure to follow the MDR regulations and for marketing medical devices without the necessary marketing clearance or approval. 

Drug manufacturers continue to receive warning letters for CGMP violations as well as misbranded drugs. CGMP violations include those related to preventing contamination, maintaining a sterile environment, and ensuring laboratory records included complete data. One manufacturer was also cited for failing to submit field alert reports within three working days of receipt of information concerning any significant change or deterioration in a distributed drug product.

FDA continues to monitor compounding pharmacies. One such pharmacy was warned after investigators noted that the pharmacy was not receiving valid prescriptions for individually identified patients. The compounding pharmacy was cited for practices that render the pharmacy ineligible for statutory exemptions from the laws that generally apply to drug manufacturers. The compounding pharmacy was additionally cited for violations relating to insanitary conditions and CGMP.

View FDA's Warning Letters homepage (scroll down for listing of recently posted Warning Letters).

The Office of Prescription Drug Promotion ("OPDP") has issued no new warning letters since the last Update.

View a complete listing of 2014 OPDP Warning Letters.

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