Recent Warning Letters – Pharmaceutical & Medical Device Regulatory Update, Vol. II, Issue 2

Since we last reported on enforcement actions in December 2014, FDA posted warning letters to drug and device manufacturers, as well as one fertility center, for violations related to CGMP (“Current Good Manufacturing Practices”), QSR (“Quality Systems Regulations”), MDR (“Medical Device Reporting”), selling unapproved animal drugs, clinical investigations, and deviations from the regulations for human cells, tissues, and cellular and tissue-based products.

FDA continues to cite medical device manufacturers for CGMP and QSR violations, including those related to design change procedures, complaints handling, process controls, corrective and preventative action procedures, and maintaining device master records. Recipients of these warning letters, three of which are located overseas, included manufacturers of coronary bypass cannulas, endoscopes, portable oxygen generators, gas flow regulators, peripheral vascular testing devices, therapeutic infrared heating lamps, neuromuscular stimulators, acupuncture needs, slings, incontinence mesh, and dental devices. Six medical device manufacturers, three of which are located abroad, were also warned for failure to follow the MDR regulations. Two medical device manufacturers, one located abroad, were cited for marketing medical devices without the necessary marketing clearance or approval. One of the firms had obtained clearance for its device but was promoting the device beyond the scope of its intended use without submitting a new premarket notification.

Drug manufacturers continue to receive warning letters for CGMP violations, as well as misbranded or unapproved drugs. CGMP violations include those related to preventing contamination and maintaining a sterile environment. FDA additionally warned an active pharmaceutical ingredient manufacturer in China for CGMP violations. A Mexican drug manufacturer was also warned for failing to pay required Generic Drug User Fee Amendments fees.

FDA continues to monitor compounding pharmacies. One such pharmacy was warned after FDA received reports of adverse events in patients who used the pharmacy’s products. 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.

FDA cited a clinical investigator for failing to properly maintain case histories and for failing to ensure the investigation adhered to the investigational plan. A fertility center received a warning letter for deviations from the relevant regulations for human cells and tissues, including failure to collect and screen donor specimens for relevant communicable diseases.

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