FDA WARNING_LETTER - Inopak, Ltd. - August 03, 2023

The FDA inspected Inopak, Ltd.'s drug manufacturing facility from July 24 to August 3, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Unit (QU):** The firm failed to establish an adequate QU, and its responsibilities were not fully followed (21 CFR 211.22(a) and 211.22(d)). The QU did not adequately review documentation from their contract manufacturing organization (CMO) to ensure required testing for methanol and other impurities (benzene, acetaldehyde, acetal) in ethanol components. They also failed to investigate leaking drug product received from the CMO or communicate the issue to the CMO. The firm's proposed sampling plan for record review was deemed inadequate, and ambiguities in the quality agreement with the CMO were noted. 2. **Lack of Stability Testing:** The firm failed to assure drug product expiration dates were supported by appropriate stability testing (21 CFR 211.137(a)). Their ongoing stability program was discontinued on January 6, 2023, despite products being labeled with expiration dates through July 29, 2024.

The FDA requires a comprehensive assessment and remediation plan for the QU, including robust procedures, oversight, complete lot review, and investigation approval. The firm must also provide an