FDA Inspection
Berkshire Sterile Manufacturing, LLCBerkshire Sterile Manufacturing, LLC – FDA Inspection, Oct 10, 2018
Record Details
This FDA Inspection record concerns Berkshire Sterile Manufacturing, LLC, with an inspection on October 10, 2018, issued by the New England District Office, covering human drugs.
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ID · 32877db4-f664-4f56-9cc1-cf221a25e853
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068306
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| August 25, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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