# FDA 483 - Acupac Packaging Inc - August 27, 2025

Source: https://www.keypedia.com/records/483/acupac-packaging-inc/6277301a-395e-44df-9c72-6522c33b2f2d

> FDA 483 for Acupac Packaging Inc on August 27, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Acupac Packaging Inc
- Inspection Date: 2025-08-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/acupac-packaging-inc/48afab9a-468b-4b23-8d96-ac5a0660a699)

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)

Company: https://www.keypedia.com/companies/acupac-packaging-inc/3e58f465-31ba-4317-bdca-42e9225f26db

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248