FDA Inspection
Berkeley Biologics LLCBerkeley Biologics LLC – FDA Inspection, Sep 25, 2023
Record Details
This FDA Inspection record concerns Berkeley Biologics LLC, with an inspection on September 25, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 03373494-ad76-49bb-9f0e-95d3f4939f30
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1218588
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.160(b)(4)Training of personnel
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.160(b)(4)Training of personnel
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of Berkeley Biologics LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2026 | Not classified | San Francisco District Office | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 28, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 25, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 17, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Berkeley Biologics LLC
- FDA Inspection 1314676 - 2026-04-29
- FDA Inspection 1145973 - 2021-06-25
- FDA Inspection 1067125 - 2018-08-28
- FDA Inspection 967555 - 2016-03-25
- FDA Inspection 765182 - 2012-02-17
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