FDA Inspection
Pacific BioLabs, Inc.Pacific BioLabs, Inc. – FDA Inspection, Jun 1, 2023
Record Details
This FDA Inspection record concerns Pacific BioLabs, Inc., with an inspection on June 1, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 656ec40f-c532-4b1f-bd74-e3eb2aa38e8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206864
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Pacific BioLabs, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | San Francisco District Office | Drug Quality Assurance |
| July 18, 2025 | Not classified | San Francisco District Office | |
| March 19, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2018 | Not classified | San Francisco District Office | |
| October 27, 2017 | Not classified | San Francisco District Office |
Other documents for Pacific BioLabs, Inc.
- FDA Inspection 1337886 - 2026-09-25
- FDA Inspection 1277213 - 2025-07-18
- FDA Inspection 1046565 - 2018-03-19
- FDA Inspection 1046401 - 2018-02-22
- FDA Inspection 1040908 - 2017-10-27
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