Andrx Pharmaceuticals, Inc.
FDA inspection history across 2 sites, 2006 to 2021
- 5
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2006: one Form 483; 2016: one Form 483; 2018: one Form 483; 2019: one close-out letter; 2020: one Form 483; 2021: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2006One Form 483, at Fort Lauderdale, Florida.
- 2016–21Three Form 483s, one close-out letter and one amended 483, at Davie, Florida.
- 2018The longest 483 on file: 10 observations over 14 pages at Davie, Florida.
Cited most
Across all Andrx Pharmaceuticals observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
The complete Andrx Pharmaceuticals file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Davie, Florida
Three Form 483s, one amended 483 and one close-out letter · 2016 to 2021 · 26 observations
Latest: Form 483, May 25, 2021 →Fort Lauderdale, Florida
One Form 483 · 2006 · 9 observations
Latest: Form 483, Apr 18, 2006 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-05-25 | Amended 483 Amended 483 | Davie, Florida | 1 | $99 |
| 2020-01-17 | 483 Form 483 | Davie, Florida | 6 | $99 |
| 2019-02-01 | Close-out Close-out letter | Davie, Florida | — | $99 |
| 2018-07-19 | 483 Form 483 | Davie, Florida | 10 | $99 |
| 2016-01-15 | 483 Form 483 | Davie, Florida | 9 | $99 |
| 2006-04-18 | 483 Form 483 | Fort Lauderdale, Florida | 9 | $99 |
Investigators on these documents
Jennifer L. Huntington (2)Cecilia Rodriguez (1)Chiaochun J. Wang (1)Fabian N. Chaparro-Rodriguez (1)Heurca Barreto-Pettit (1)Ileana Barreto-Pettit (1)Joanne E. King (1)Jogy George (1)Ademola O. Daramola (1)Stephanie D. Crockett (1)
FEI number 3003194604 · most recent document May 25, 2021
About Andrx Pharmaceuticals, Inc.
How many FDA Form 483s has Andrx Pharmaceuticals, Inc. received?
FDA Intel has 5 Form 483s on file for Andrx Pharmaceuticals, Inc.; the most recent is dated May 25, 2021.
When was Andrx Pharmaceuticals, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Andrx Pharmaceuticals, Inc. is a Form 483 dated May 25, 2021, for the site in Davie, Florida.
What did FDA cite at Andrx Pharmaceuticals, Inc.?
The regulations cited most in the observations on file for Andrx Pharmaceuticals, Inc. are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 5 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times.