# FDA 483 - Unipack LLC - June 30, 2025

Source: https://www.globalkeysolutions.net/records/483/unipack-llc/aecd8423-febc-4e62-816d-4e029d0fc841

> FDA 483 for Unipack LLC on June 30, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Unipack LLC
- Inspection Date: 2025-06-30
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Documents

- [483 - 2020-10-16](https://www.globalkeysolutions.net/records/483/unipack-llc/f3b8ff8d-b003-4dfd-859f-5dd7b9f3feff)
- [483 - 2022-03-25](https://www.globalkeysolutions.net/records/483/unipack-llc/f6d83786-a859-4ea4-a63e-0ba3e6708a34)
- [WARNING_LETTER - 2025-06-30](https://www.globalkeysolutions.net/records/warning_letter/unipack-llc/8ab0ff88-9632-4f10-beef-15d6e8c00628)

## Related Officers

- [Director of Clinical Training](https://www.globalkeysolutions.net/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)
- [John D. McIntosh](https://www.globalkeysolutions.net/people/john-d-mcintosh/063cac5b-0933-4ecf-a9fb-835dd5d25ef2)
- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.globalkeysolutions.net/companies/unipack-llc/31b9e50c-e551-4f7c-a6bc-c52197dcb7c5

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