# FDA 483 - Universal Packaging Systems, Inc. dba PakLab - March 17, 2023

Source: https://www.keypedia.com/records/483/universal-packaging-systems-inc-dba-paklab/4d5ad6fa-fc9b-4b49-b715-7f13ff0f90a2

> FDA 483 for Universal Packaging Systems, Inc. dba PakLab on March 17, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Universal Packaging Systems, Inc. dba PakLab
- Inspection Date: 2023-03-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Paklab, a contract manufacturer in Chino, CA, was cited with five observations during an FDA inspection. The firm failed to establish adequate procedures for water system and cleaning validations, lacked specific identification tests for components, and maintained unsanitary building conditions. Additionally, issues were noted with routine checking of electronic laboratory equipment and the design and maintenance of manufacturing equipment, including significant leaks.

## Related Documents

- [483 - 2023-11-17](https://www.keypedia.com/records/483/universal-packaging-systems-inc-dba-paklab/35cd49bf-b37d-49b0-93c6-fbbc536aa89f)
- [483 - 2025-05-29](https://www.keypedia.com/records/483/universal-packaging-systems-inc-dba-paklab/137e921e-5f14-4aa1-9e35-48e30dd9282b)

## Related Officers

- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)

Company: https://www.keypedia.com/companies/universal-packaging-systems-inc-dba-paklab/990f7815-ae74-4d4f-a933-76c08c03be3b

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6