FDA Inspection
Teva Parenteral Medicines, Inc.Teva Parenteral Medicines, Inc. – FDA Inspection, Jan 18, 2019
Record Details
This FDA Inspection record concerns Teva Parenteral Medicines, Inc., with an inspection on January 18, 2019, issued by the Los Angeles District Office, covering human drugs.
View Company Profile
ID · e47fc7f6-00f8-4471-b12c-3986a95c6d45
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077528
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(e)Test methods
Full citation text and observation details available on the Dashboard.
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 |
| 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 1100853 - 2019-08-30
- FDA Inspection 997582 - 2016-12-19
- FDA Inspection 980903 - 2016-07-29
- FDA Inspection 882240 - 2014-06-06
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.