FDA Inspection
Anicare Pharmaceuticals Pvt Ltd.Anicare Pharmaceuticals Pvt Ltd. – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns Anicare Pharmaceuticals Pvt Ltd., with an inspection on August 3, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 530ba2e2-557c-49b1-b242-3a199c99afb1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1061011
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.110(a)(3)Mixing adequacy
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Anicare Pharmaceuticals Pvt Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 14, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Anicare Pharmaceuticals Pvt Ltd.
- FDA Inspection 1195342 - 2023-01-20
- FDA Inspection 978860 - 2016-07-14
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