FDA 483 - Acupac Packaging Inc - August 27, 2025

Acupac Packaging Inc. in Mahwah, NJ, was cited by the FDA for significant deficiencies in its process validation practices during an inspection from August 18-27, 2025. The firm's Validation Master Plan was found inadequate, failing to ensure processes are validated with a high degree of assurance. A specific process validation report also lacked assurance, as it did not account for potential variability in bulk materials or worst-case production volumes.