Teva Parenteral Medicines, Inc.
FDA inspection history across 2 sites, 2009 to 2021
- 8
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter and one Form 483; 2010: one Form 483; 2012: one Form 483; 2013: one Form 483; 2016: one Form 483; 2019: two Form 483s; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–13Four Form 483s and one warning letter, at Irvine, California and . Irvine, California.
- 2009The longest 483 on file: 14 observations over 10 pages at . Irvine, California.
- 2016One Form 483, at Irvine, California.
- 2019–21Three Form 483s, at Irvine, California.
Cited most
Across all Teva Parenteral Medicines observations on file
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.165Testing and release for distribution5
- 21 CFR 211.192Production record review5
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination4
The complete Teva Parenteral Medicines file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Irvine, California
Seven Form 483s and one warning letter · 2009 to 2021 · 26 observations
Latest: Form 483, Aug 20, 2021 →. Irvine, California
One Form 483 · 2009 · 14 observations
Latest: Form 483, Jul 24, 2009 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-20 | 483 Form 483 | Irvine, California | 10 | $99 |
| 2019-08-30 | 483 Form 483 | Irvine, California | 6 | $99 |
| 2019-01-18 | 483 Form 483 | Irvine, California | 4 | $99 |
| 2016-07-29 | 483 Form 483 | Irvine, California | 3 | $99 |
| 2013-06-04 | 483 Form 483 | Irvine, California | 1 | $99 |
| 2012-04-24 | 483 Form 483 | Irvine, California | 2 | $99 |
| 2010-05-14 | 483 Form 483 | Irvine, California | — | $99 |
| 2009-12-11 | Warning letter Warning letter | Irvine, California | — | $99 |
| 2009-07-24 | 483 Form 483 | . Irvine, California | 14 | $99 |
Investigators on these documents
Amir Alavi (2)Adam R. Cooke (1)Amanda L. Fyles (1)Binh T. Nguyen (1)Carla J. Lundi (1)Jennifer M. Gogley (1)Joey V. Quitania (1)Kham Phommachanh (1)Linda F. Murphy (1)Marcus F. Yambot (1)Sangeeta M. Khurana (1)Santiago Gallardo Johnson (1)
FEI number 2027158 · most recent document Aug 20, 2021
About Teva Parenteral Medicines, Inc.
How many FDA Form 483s has Teva Parenteral Medicines, Inc. received?
FDA Intel has 8 Form 483s on file for Teva Parenteral Medicines, Inc.; the most recent is dated Aug 20, 2021.
When was Teva Parenteral Medicines, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Teva Parenteral Medicines, Inc. is a Form 483 dated Aug 20, 2021, for the site in Irvine, California.
What did FDA cite at Teva Parenteral Medicines, Inc.?
The regulations cited most in the observations on file for Teva Parenteral Medicines, Inc. are 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.165 (Testing and release for distribution), 5 times; 21 CFR 211.192 (Production record review), 5 times.
Has Teva Parenteral Medicines, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Teva Parenteral Medicines, Inc.; the most recent is dated Dec 11, 2009.