FDA Inspection
Emcure Pharmaceuticals LimitedEmcure Pharmaceuticals Limited – FDA Inspection, Feb 20, 2019
Record Details
This FDA Inspection record concerns Emcure Pharmaceuticals Limited, with an inspection on February 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 76eb095f-f6e8-47da-83e0-201f42655ab1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1079858
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Emcure Pharmaceuticals Limited
9| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 17, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 4, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Emcure Pharmaceuticals Limited
- FDA Inspection 1075227 - 2018-10-30
- FDA Inspection 1023101 - 2017-08-17
- FDA Inspection 912371 - 2015-02-04
- FDA Inspection 867389 - 2014-02-07
- FDA Inspection 834734 - 2013-04-26
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