FDA Inspection
Teva Parenteral Medicines, Inc.Teva Parenteral Medicines, Inc. – FDA Inspection, Aug 20, 2021
Record Details
This FDA Inspection record concerns Teva Parenteral Medicines, Inc., with an inspection on August 20, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 20, 2021
- Product Type
- Drugs
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ID · ff5b4440-dec5-48d1-8ee4-005907b133c2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1149378
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 212.60(e)Equipment
- 21 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Teva Parenteral Medicines, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 6, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Parenteral Medicines, Inc.
- FDA Inspection 1100853 - 2019-08-30
- 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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