FDA Inspection
Berkshire Sterile Manufacturing, LLCBerkshire Sterile Manufacturing, LLC – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns Berkshire Sterile Manufacturing, LLC, with an inspection on April 13, 2018, issued by the New England District Office, covering human drugs.
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ID · 9372f72c-8871-4b07-ba99-dcf249438c98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049626
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.84(d)(3)Establish reliability of supplier's C of A
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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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