FDA Inspection
Galentic Pharma (India) Pvt. LtdGalentic Pharma (India) Pvt. Ltd – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns Galentic Pharma (India) Pvt. Ltd, with an inspection on February 24, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Ivy E. Sweeney (Issuing Officer)
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ID · a1667bc1-fe36-400c-93c4-7f0fb4023c27
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1004955
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
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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 |
| December 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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