FDA 483 - Unipack LLC - June 30, 2025

Unipack LLC received a Form 483 citing significant deficiencies across multiple areas of its manufacturing and quality control operations. Observations included inadequate process validation, lack of established hold times, widespread data integrity issues in the QC laboratory, and failures in OOS investigations. Additionally, the firm was cited for unvalidated test methods, missing product specifications, stability program deviations, and poor facility and equipment maintenance, indicating a systemic lack of control over drug product quality and purity.