FDA recently published warning letters to several medical device manufacturers. Two medical device manufacturers failed to comply with the Quality Systems Regulation. The warning letters cite several violations, including inadequate procedures for supplier qualifications, inadequate controls for the device design, failure to implement corrective and preventative actions, and improper documentation of complaint investigations. The Agency warned a third manufacturer for failing to obtain 510(k) clearance before marketing its products. After finding another manufacturer's product to be adulterated, FDA issued a warning letter citing numerous violations related to the quality system regulation.

FDA also warned a pharmaceutical compounding company for not having valid prescriptions for its drug products and for producing drug products in a nonsterile environment.

Click here for FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).

The Office of Prescription Drug Promotion ("OPDP") issued three untitled letters to drug manufacturers for omitting risk information or material facts.

Click here for a complete listing of 2014 OPDP Warning Letters.

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