FDA Inspection
Galentic Pharma (India) Pvt. LtdGalentic Pharma (India) Pvt. Ltd – FDA Inspection, Dec 8, 2022
Record Details
This FDA Inspection record concerns Galentic Pharma (India) Pvt. Ltd, with an inspection on December 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 8, 2022
- Product Type
- Drugs
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ID · e4280e94-44b8-416f-a9c6-f952157d430c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192232
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Galentic Pharma (India) Pvt. Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| February 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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