FDA Inspection
Galentic Pharma (India) Private LimitedGalentic Pharma (India) Private Limited – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Galentic Pharma (India) Private Limited, with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Ivy E. Sweeney (Issuing Officer)
View Company Profile
ID · 90e74077-bece-4873-8eb8-9bca4f32d481
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1006302
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Galentic Pharma (India) Private Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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