FDA Hands Aplicare Warning Letter Over Sterility Controls

Aplicare landed an FDA warning letter after an inspection uncovered four significant GMP violations involving sterility controls and marketing claims for unapproved uses.

FDA investigators found Aplicare neglected to implement adequate microbial controls for its povidone-iodine drugs and failed to validate its sterilization process, which resulted in the contamination of the company’s povidone-iodine solution, ointment and gel.

Aplicare also failed to use air filtration systems in its manufacturing areas to maintain the appropriate air quality and cleanliness for drug production, the FDA said, calling the conditions “inadequate” to ensure sterility and protect drugs from contamination.