# Pacific BioLabs, Inc. – FDA 483, Jun 1, 2023

Source: https://www.keypedia.com/records/483/pacific-biolabs-inc/675f11c1-ba78-4336-ac5f-61d44e74def8

> FDA 483 for Pacific BioLabs, Inc. on June 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacific BioLabs, Inc.
- Inspection Date: 2023-06-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Pacific BioLabs, a control testing laboratory in Hercules, CA, was cited for significant deficiencies in its quality system and laboratory controls. The inspection revealed widespread failures to follow written procedures, inadequate investigation of deviations and out-of-specification results, and insufficient control over laboratory records and electronic data. These issues indicate a systemic breakdown in maintaining data integrity and ensuring the reliability of testing results.

## Related Documents

- [483 - 2025-07-18](https://www.keypedia.com/records/483/pacific-biolabs-inc/6c2ddbd0-7795-4e65-8109-db1d04722969) — date: July 18, 2025
- [EIR - 2018-03-19](https://www.keypedia.com/records/eir/pacific-biolabs-inc/54dcc998-78cc-49a2-a764-2118e76569d1) — date: March 19, 2018

## Related Officers

- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)
- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

Company: https://www.keypedia.com/companies/pacific-biolabs-inc/3b9d5ef3-bc95-4934-9be0-40c8534a1bde

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b