FDA Inspection
Teva Puerto Rico LLCTeva Puerto Rico LLC – FDA Inspection, Mar 6, 2015
Record Details
This FDA Inspection record concerns Teva Puerto Rico LLC, with an inspection on March 6, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Teva Puerto Rico LLC
- Inspection Date
- March 6, 2015
- Product Type
- Drugs
View Company Profile
ID · b6c820e5-e0da-4642-9cb1-6454ceca75d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920580
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
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 |
| 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 1010797 - 2017-03-03
- FDA Inspection 826944 - 2013-04-11
- FDA Inspection 800308 - 2012-09-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.