FDA Inspection
Teva Puerto Rico LLCTeva Puerto Rico LLC – FDA Inspection, Jul 29, 2011
Record Details
This FDA Inspection record concerns Teva Puerto Rico LLC, with an inspection on July 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Teva Puerto Rico LLC
- Inspection Date
- July 29, 2011
- Product Type
- Drugs
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ID · b2bda4a3-d247-4db1-9238-a46cbc647552
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 736833
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 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 Teva Puerto Rico LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 23, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 10, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Puerto Rico LLC
- FDA Inspection 1193314 - 2022-11-23
- FDA Inspection 1064456 - 2018-08-10
- FDA Inspection 1010797 - 2017-03-03
- FDA Inspection 920580 - 2015-03-06
- FDA Inspection 826944 - 2013-04-11
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