FDA Inspection
Anicare Pharmaceuticals Pvt Ltd.Anicare Pharmaceuticals Pvt Ltd. – FDA Inspection, Jan 20, 2023
Record Details
This FDA Inspection record concerns Anicare Pharmaceuticals Pvt Ltd., with an inspection on January 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8abf3923-4f0b-4ad4-9720-6feda23b7fa1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1195342
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.101(b)Identification of new containers
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Other FDA inspections of Anicare Pharmaceuticals Pvt Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | 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 1061011 - 2018-08-03
- FDA Inspection 978860 - 2016-07-14
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