FDA Inspection
Teva Puerto Rico LLCTeva Puerto Rico LLC – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Teva Puerto Rico LLC, with an inspection on March 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f53a2c82-7934-4a5a-9d85-ca1b89dadb69
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1010797
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(a)Procedures for non-sterile drug products
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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 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 |
| September 13, 2012 | NAI | 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 920580 - 2015-03-06
- FDA Inspection 826944 - 2013-04-11
- FDA Inspection 800308 - 2012-09-13
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