FDA EIR - Aphena Pharma Solutions - Tennessee LLC - November 16, 2017

An FDA inspection of Aphena Pharma Solutions-Tennessee, LLC (APST), a drug repacker and relabeler, was conducted from November 14-16, 2017. The inspection, performed under regulatory frameworks for drug repackers and relabelers (CP 7356.002B and CP 7346.832) and Good Manufacturing Practices (21 CFR Part 211), identified three main observations. Firstly, the quality control unit's responsibilities were not fully followed, evidenced by a lack of corrective actions for complaint investigations, failure to investigate humidity excursions, and an unclosed nonconformance report regarding contaminated desiccants. Secondly, the firm lacked written procedures to ensure drug product identity and quality, specifically noting that primary packaging suites with environmental controls were used without prior qualification. Thirdly, deficiencies were found in maintaining separate areas to prevent contamination; both primary and secondary packaging, including cardboard box assembly, occurred concurrently in the same suite where bulk drugs were handled. Firm management committed to immediate corrections and promised a written response to the FDA 483 observations.