FDA Inspection
Apotex Research Private LimitedApotex Research Private Limited – FDA Inspection, Jul 1, 2014
Record Details
This FDA Inspection record concerns Apotex Research Private Limited, with an inspection on July 1, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 1, 2014
- Product Type
- Drugs
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ID · 1c1b9333-1100-480a-bebd-bbd7a0469801
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 886801
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 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 Apotex Research Private Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2024 | VAI | Generic Drug Evaluation | |
| February 2, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 17, 2017 | Not classified | Office of Inspections and Investigations | |
| May 20, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Apotex Research Private Limited
- FDA Inspection 1233067 - 2024-03-15
- FDA Inspection 1081769 - 2019-02-02
- FDA Inspection 1035038 - 2017-11-17
- FDA Inspection 970670 - 2016-05-20
- FDA Inspection 851564 - 2013-07-12
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