FDA Inspection
Teva Parenteral Medicines, Inc.Teva Parenteral Medicines, Inc. – FDA Inspection, Aug 30, 2019
Record Details
This FDA Inspection record concerns Teva Parenteral Medicines, Inc., with an inspection on August 30, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a0419dde-20ca-4421-89a3-71c798a81f81
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1100853
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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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 |
| 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 |
| June 6, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Parenteral Medicines, Inc.
- FDA Inspection 1149378 - 2021-08-20
- FDA Inspection 1077528 - 2019-01-18
- FDA Inspection 997582 - 2016-12-19
- FDA Inspection 980903 - 2016-07-29
- FDA Inspection 882240 - 2014-06-06
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