FDA Inspection
Berkshire Sterile Manufacturing, LLCBerkshire Sterile Manufacturing, LLC – FDA Inspection, Aug 25, 2023
Record Details
This FDA Inspection record concerns Berkshire Sterile Manufacturing, LLC, with an inspection on August 25, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fc1f3ae4-1437-434d-ae81-c02182a4a89a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216061
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Berkshire Sterile Manufacturing, LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2026 | Not classified | New England District Office | Drug Quality Assurance |
| October 21, 2024 | Not classified | New England District Office | |
| June 12, 2024 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 20, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 15, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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