# Pacific BioLabs, Inc. – FDA 483, Jul 18, 2025

Source: https://www.keypedia.com/records/483/pacific-biolabs-inc/6c2ddbd0-7795-4e65-8109-db1d04722969

> FDA 483 for Pacific BioLabs, Inc. on July 18, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacific BioLabs, Inc.
- Inspection Date: 2025-07-18
- Product Type: other
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Pacific Biolabs, Inc. in Hercules, CA, a nonclinical laboratory, revealed significant deficiencies in documentation, data integrity, and quality assurance practices. Observations included failures to characterize test articles and challenge agents, conduct dose formulation analyses, document protocol deviations, and accurately record experimental data and material quantities. These issues indicate a lack of control over critical aspects of nonclinical studies.

## Related Documents

- [483 - 2023-06-01](https://www.keypedia.com/records/483/pacific-biolabs-inc/675f11c1-ba78-4336-ac5f-61d44e74def8) — date: June 1, 2023
- [EIR - 2018-03-19](https://www.keypedia.com/records/eir/pacific-biolabs-inc/54dcc998-78cc-49a2-a764-2118e76569d1) — date: March 19, 2018

## Related Officers

- [Andrew R. Wasko](https://www.keypedia.com/people/andrew-r-wasko/87f194a2-d86b-4dad-8319-07f107ad8e6a)
- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

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

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df