Since we last reported on enforcement actions in early November, 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 human and 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 failure to establish adequate procedures for design changes, inadequate handling of complaints, insufficient process controls, failure to establish and maintain procedures for corrective and preventative action, and failure to establish procedures for quality audits. Recipients of recently posted warning letters for CGMP and QSR violations, five of which are located overseas, included manufacturers of massage devices, catheters, surgical sutures, tests for Phadebact monoclonal GC, H. Influenza, and CSF, saline and heparin flush syringes, blood collection tubes, and intravenous sets, poles, and syringes. FDA also cited four medical device manufacturers for failure to follow the MDR regulations.
Drug manufacturers continue to receive warning letters for CGMP violations, as well as misbranded or unapproved drugs. CGMP violations include insanitary conditions and inadequate quality controls. FDA additionally warned two drug manufacturing facilities, both located in India, for CGMP violations related to the manufacture of active pharmaceutical ingredients. One of the facilities was also warned for failing to register the facility prior to offering the drug for import into the United States.
FDA continues to monitor compounding pharmacies, recently posting three warning letters, citing one such pharmacy for failing to obtain valid prescriptions for its compounded products, a practice that renders the pharmacy ineligible for statutory exemptions to laws that would otherwise apply to drug manufacturers. The compounding pharmacies were additionally cited for violations relating to insanitary conditions, CGMP, and selling unapproved drug products.
FDA cited a clinical investigator of an investigational drug for failing to ensure the investigation was conducted according to the investigational plan. A fertility center received a warning letter for deviations from the regulations for human cells, tissues, and cellular and tissue-based products, including failure to screen donor specimens for infections and failure to determine as ineligible donors with risk factors for certain diseases.
Finally, FDA recently posted five warning letters to veterinary companies, three located overseas, that sell animal drugs online for marketing numerous unapproved new animal drugs.
View FDA's Warning Letters homepage (scroll down for listing of recently posted Warning Letters).
Since the last Update, the Office of Prescription Drug Promotion ("OPDP") issued an untitled letter to a drug manufacturer stating its seizure medication's promotion was misleading, citing the inclusion of claims that the drug is more effective than has been demonstrated by substantial evidence. In this letter, FDA highlighted promotional claims associated with patient-reported outcomes used without apparent adequate substantiation. The untitled letter represents OPDP's 10th letter of 2014.
View a complete listing of 2014 OPDP Warning Letters.
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