FDA Inspection
Berkeley Advanced Biomaterials, LLCBerkeley Advanced Biomaterials, LLC – FDA Inspection, Nov 22, 2024
Record Details
This FDA Inspection record concerns Berkeley Advanced Biomaterials, LLC, with an inspection on November 22, 2024, issued by the San Francisco District Office, covering biologics.
- Person
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ID · 6154b1fd-30a1-460e-b93d-3403dd5afc7e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1256931
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.270(a)Records incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Berkeley Advanced Biomaterials, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 28, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 12, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Berkeley Advanced Biomaterials, LLC
- FDA Inspection 1102665 - 2019-09-05
- FDA Inspection 1105222 - 2019-08-02
- FDA Inspection 978232 - 2016-06-28
- FDA Inspection 983348 - 2016-04-18
- FDA Inspection 839484 - 2013-07-12
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