Company
United StatesTeva Parenteral Medicines, Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for Teva Parenteral Medicines, Inc. in Irvine, California. 12 FDA inspections on record (2 OAI), 2 Form 483s, last inspected August 20, 2021.
Company Profile
This profile covers Teva Parenteral Medicines, Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 2
- VAI
- 4
- NAI
- 6
- Form 483s
- 2
- Warning letters
- 0
First inspected July 24, 2009. Last inspected August 20, 2021.
Most cited issue areas
- Absence of Written Procedures3 inspections
- Environmental Monitoring System3 inspections
- Investigations of discrepancies, failures3 inspections
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 20, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1149378 |
| August 30, 2019 | NAI | Human Drugs · New Drug Evaluation | 1100853 |
| January 18, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1077528 |
| December 19, 2016 | NAI | Human Drugs · Drug Quality Assurance | 997582 |
| July 29, 2016 | VAI | Human Drugs · Drug Quality Assurance | 980903 |
| June 6, 2014 | NAI | Human Drugs · Drug Quality Assurance | 882240 |
| June 4, 2013 | VAI | Human Drugs · Drug Quality Assurance | 834806 |
| August 10, 2012 | NAI | Human Drugs · Drug Quality Assurance | 794284 |
| April 24, 2012 | VAI | Human Drugs · Drug Quality Assurance | 779321 |
| May 14, 2010 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 661280 |
| February 1, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645199 |
| July 24, 2009 | OAI | Human Drugs · Drug Quality Assurance | 603521 |
FDA documents
Form 483s (9)
Other regulators (1)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Teva Parenteral Medicines, Inc.
FEI Number
2027158
Address
19 Hughes, Irvine, California 92618, United States
Country
United States
ID: 0fca6486-3040-4806-b72d-ff1c31d675c1