Company
United StatesPacific BioLabs, Inc., Hercules, CA – FDA Inspections
Inspection records and compliance data for Pacific BioLabs, Inc. in Hercules, California. 12 FDA inspections on record, 4 Form 483s, last inspected September 25, 2026.
Company Profile
This profile covers Pacific BioLabs, Inc. based in Hercules, California, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 3
- NAI
- 5
- Unclassified
- 4
- Form 483s
- 4
- Warning letters
- 0
First inspected June 4, 2009. Last inspected September 25, 2026.
Most cited issue areas
- Written record of investigation incomplete3 inspections
- Procedures not in writing, fully followed2 inspections
- Calibration/Inspection/Checking not done1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1337886 |
| July 18, 2025 | Not classified | Human Drugs | 1277213 |
| June 1, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1206864 |
| March 19, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1046565 |
| February 22, 2018 | Not classified | Medical Devices & Rad Health | 1046401 |
| October 27, 2017 | Not classified | Human Drugs | 1040908 |
| October 30, 2013 | VAI | Human Drugs · Drug Quality Assurance | 851917 |
| October 19, 2010 | NAI | Human Drugs · Drug Quality Assurance | 694550 |
| May 24, 2010 | NAI | Human Drugs · Drug Quality Assurance | 663601 |
| September 18, 2009 | NAI | Human Drugs · Drug Quality Assurance | 613017 |
| September 9, 2009 | NAI | Human Drugs · Drug Quality Assurance | 610863 |
| June 4, 2009 | NAI | Human Drugs · Drug Quality Assurance | 590387 |
FDA documents
Form 483s (2)
EIRs (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Pacific BioLabs, Inc.
FEI Number
2914117
Address
551 Linus Pauling Dr, Hercules, California 94547, United States
Country
United States
ID: 3b9d5ef3-bc95-4934-9be0-40c8534a1bde