FDA WARNING_LETTER - Unipack LLC - June 30, 2025

The FDA issued a Warning Letter to Unipack LLC on December 19, 2025, following an inspection of their South Plainfield, NJ, drug manufacturing facility from June 11 to June 30, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in their drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included a failure to thoroughly investigate unexplained discrepancies or failures, such as out-of-specification (OOS) results for suppository stability and content uniformity, and uninvestigated unknown peaks in High-Performance Liquid Chromatography (HPLC) chromatograms. For example, Unipack invalidated OOS results without adequate scientific justification or identified laboratory error, and released products despite unresolved issues. Additionally, the firm failed to ensure laboratory records contained complete data, with non-contemporaneous entries observed.

The FDA found Unipack"s responses to be inadequate, particularly regarding root cause determination and proposed corrective actions. The agency requires Unipack to conduct a comprehensive, independent assessment and remediation plan for their systems related to investigations of deviations, OOS results, and their Corrective and Preventive Action (CAPA) program. They must also perform a retrospective review of all invalidated OOS results for currently marketed U.S. products and provide a thorough assessment of their test methods. These actions are crucial to ensure the quality and safety of their drug products.