FDA Inspection
Teva Parenteral Medicines, Inc.Teva Parenteral Medicines, Inc. – FDA Inspection, Jul 24, 2009
Record Details
This FDA Inspection record concerns Teva Parenteral Medicines, Inc., with an inspection on July 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 24, 2009
- Product Type
- Drugs
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ID · 220bdfb4-c9ee-463f-a61e-e7f2acdfc7f4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 603521
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.192Extent of discrepancy, failure investigations
Showing 10 of 16 citations.
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Other FDA inspections of Teva Parenteral Medicines, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2019 | NAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| January 18, 2019 | VAI | Los Angeles District Office | Generic Drug Evaluation |
| December 19, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Parenteral Medicines, Inc.
- FDA Inspection 1149378 - 2021-08-20
- FDA Inspection 1100853 - 2019-08-30
- FDA Inspection 1077528 - 2019-01-18
- FDA Inspection 997582 - 2016-12-19
- FDA Inspection 980903 - 2016-07-29
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