Impax Laboratories, Inc.
FDA inspection history in Hayward, California, 2011 to 2016
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2012: one Form 483; 2013: one Form 483; 2015: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–16Four Form 483s and one warning letter, at Hayward, California.
- 2013The longest 483 on file: 12 observations over 12 pages at Hayward, California.
Cited most
Across all Impax Laboratories observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 314.80Postmarketing reporting of adverse drug experiences3
- 21 CFR 211.100(b)Written procedures; deviations1
The complete Impax Laboratories file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Hayward, California
Four Form 483s and one warning letter · 2011 to 2016 · 24 observations
Latest: Form 483, May 4, 2016 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-05-04 | 483 Form 483 | Hayward, California | 4 | $99 |
| 2015-05-08 | 483 Form 483 | Hayward, California | 3 | $99 |
| 2013-02-28 | 483 Form 483 | Hayward, California | 12 | $99 |
| 2012-03-28 | 483 Form 483 | Hayward, California | 5 | $99 |
| 2011-05-31 | Warning letter Warning letter | Hayward, California | — | $99 |
Investigators on these documents
Stephanie A. Slater (2)Lucila B. Nwatu (2)Daniel J. Roberts (1)Elizabeth Juarez (1)Kim L. Thomas Cruse (1)Peter E. Baker (1)Rebecca Rodriguez (1)Uduak M. Inokon (1)V. Millar (1)Anh Lac (1)Walden H. Lee (1)Ashar P. Parikh (1)
FEI number 3004182921 · most recent document May 4, 2016
About Impax Laboratories, Inc.
How many FDA Form 483s has Impax Laboratories, Inc. received?
FDA Intel has 4 Form 483s on file for Impax Laboratories, Inc.; the most recent is dated May 4, 2016.
When was Impax Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Impax Laboratories, Inc. is a Form 483 dated May 4, 2016, for the site in Hayward, California.
What did FDA cite at Impax Laboratories, Inc.?
The regulations cited most in the observations on file for Impax Laboratories, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.
Has Impax Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Impax Laboratories, Inc.; the most recent is dated May 31, 2011.