FDA Inspection
Berkshire Sterile Manufacturing, LLCBerkshire Sterile Manufacturing, LLC – FDA Inspection, Oct 27, 2020
Record Details
This FDA Inspection record concerns Berkshire Sterile Manufacturing, LLC, with an inspection on October 27, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 27, 2020
- Product Type
- Drugs
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ID · 96922145-9de3-4fd8-b1ee-16cbc06d6810
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1132516
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/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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