FDA Inspection
Teva Puerto Rico LLCTeva Puerto Rico LLC – FDA Inspection, Dec 29, 2009
Record Details
This FDA Inspection record concerns Teva Puerto Rico LLC, with an inspection on December 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Teva Puerto Rico LLC
- Inspection Date
- December 29, 2009
- Product Type
- Drugs
View Company Profile
ID · 9b280d7f-d85f-4e63-985e-bae2e08d5227
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636239
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.111Establishment of time limitations
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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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