FDA Inspection
Berkeley Biologics LLCBerkeley Biologics LLC – FDA Inspection, Apr 29, 2026
Record Details
This FDA Inspection record concerns Berkeley Biologics LLC, with an inspection on April 29, 2026, issued by the San Francisco District Office, covering biologics.
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ID · f4ebc4b8-f7a8-4bc4-88b5-16bf9b1dea50
Inspection Facts
- Inspection number
- 1314676
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.210(a)Use prior to verification
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 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 |
|---|---|---|---|
| September 25, 2023 | OAI | Center for Biologics Evaluation and Research | 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 1218588 - 2023-09-25
- 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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