Handling of Microbiological Deviations and Sterility Testing - FDA issues Warning Letter

A few years ago, following nearly 800 meningitis cases linked to the New England Compounding Center, the FDA intensified scrutiny of compounding facilities, resulting in numerous Warning Letters, notably in 2012 and 2013. Recently, the FDA issued a Warning Letter to Central Admixture Pharmacy Services due to serious deficiencies uncovered during inspections from February 27 to March 30, 2023. These lapses, particularly in sterile manufacturing, pose risks to patient safety. Despite a 483 response and a voluntary recall of sterile drug products, the FDA found ongoing non-compliance with FDCA and GMP regulations.

The FDCA allows "outsourcing facilities" certain exemptions, but compliance with GMP regulations is mandatory. Violations found during the inspection include unhygienic conditions and inadequate assessment of microbial contamination. The FDA outlined additional violations, including failure to investigate deviations and lack of laboratory standards. Despite responses and recalls, the FDA deemed corrective actions insufficient, particularly regarding SOPs and sterility testing methods.

The FDA emphasizes the company's responsibility for ensuring quality even when utilizing external facilities and advises comprehensive assessments of global manufacturing processes.