# FDA 483 - Paxeuticals LLC - April 20, 2026

Source: https://www.keypedia.com/records/483/paxeuticals-llc/5f71b49b-45af-4c46-a0b1-b44e1f8e7ba5

> FDA 483 for Paxeuticals LLC on April 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paxeuticals LLC
- Inspection Date: 2026-04-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: During an inspection from April 14-20, 2026, Paxuticals LLC, a contract packager in Parsippany, NJ, received six observations related to significant deficiencies in their manufacturing and quality control processes. The firm failed to establish adequate production and process controls, properly qualify equipment, maintain a functional quality control unit, ensure equipment cleanliness, maintain complete batch records, and store drug products under appropriate conditions.

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/paxeuticals-llc/41ad7ee3-fe96-4359-8922-41d6d5f5d5c2

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