There have been several enforcement actions made public since the last Jones Day Pharmaceutical & Medical Device Regulatory Update.
FDA recently warned six medical device manufacturers for failing to comply with the Quality Systems Regulation. According to the warning letters, the companies had inadequate procedures for process validation, environmental controls, handling customer complaints, and corrective and preventive actions. The Agency also took action against a manufacturer of biological products for CGMP violations observed at its facility in Mexico.
In another action, FDA cited a compounding pharmacy for not having valid individual prescriptions for each drug produced and for operating in unsanitary conditions.
There also has been an uptick in enforcement actions related to laboratory and clinical studies. FDA recently warned a pathology laboratory for failing to adhere to Good Laboratory Practice regulations during two nonclinical studies. In addition, the Agency posted warning letters related to Investigational Device Exemptions and Institutional Review Board violations, including one notice to a sponsor/clinical investigator.
Click here for FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).
According to its website, the Office of Prescription Drug Promotion ("OPDP") has issued no warning letters in the last 60 days.
Click here for a complete listing of 2014 OPDP Warning Letters.
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