FDA Inspection
Glenmark Generics S.A.Glenmark Generics S.A. – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Glenmark Generics S.A., with an inspection on December 8, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · fa681323-0f88-431c-aeda-9cd2b965a35e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1000258
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Glenmark Generics S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glenmark Generics S.A.
- FDA Inspection 882565 - 2014-05-27
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