FDA Inspection
The General Hospital CorporationThe General Hospital Corporation – FDA Inspection, Sep 30, 2025
Record Details
This FDA Inspection record concerns The General Hospital Corporation, with an inspection on September 30, 2025, issued by the New England District Office, covering human drugs.
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ID · fa5a23da-8249-48e2-9bcb-21616c97ed7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1284676
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
7- 21 CFR 212.110(b)Record quality
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.30(b)Equipment procedures
- 21 CFR 212.50(a)Written control procedures
- 21 CFR 212.50(d)Production area & equipment checks
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of The General Hospital Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for The General Hospital Corporation
- FDA Inspection 1171766 - 2022-06-13
- FDA Inspection 884781 - 2014-06-13
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