Caraco Pharmaceutical Laboratories, Ltd.
FDA inspection history in Detroit, Michigan, 2008 to 2020
- 4
- Form 483s
Every document, by year
- Form 483
2008: one Form 483; 2009: one Form 483; 2013: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008–09Two Form 483s, at Detroit, Michigan.
- 2009The longest 483 on file: 16 observations over 14 pages at Detroit, Michigan.
- 2013One Form 483, at Detroit, Michigan.
- 2020One Form 483, at Detroit, Michigan.
Cited most
Across all Caraco Pharmaceutical Laboratories observations on file
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.25Personnel qualifications3
- 21 CFR 211.67Equipment cleaning and maintenance3
The complete Caraco Pharmaceutical Laboratories file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Detroit, Michigan
Four Form 483s · 2008 to 2020 · 33 observations
Latest: Form 483, May 30, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-05-30 | 483 Form 483 | Detroit, Michigan | 1 | $99 |
| 2013-01-11 | 483 Form 483 | Detroit, Michigan | 2 | $99 |
| 2009-03-16 | 483 Form 483 | Detroit, Michigan | 16 | $99 |
| 2008-06-11 | 483 Form 483 | Detroit, Michigan | 14 | $99 |
Investigators on these documents
Rebecca E. Dombrowski (2)Patsy J. Domingo (2)Aurora-Miha Trifanov (1)Caroline H. Le (1)Daniel J. Brown (1)Emily J. Orban (1)L'oreal D. Fowlkes (1)Regina Brown (1)Robert M. Barbosa (1)Andrea F. White (1)Tracey L. Taylor (1)Andrew J. Idzior (1)
FEI number 1833173 · most recent document May 30, 2020
About Caraco Pharmaceutical Laboratories, Ltd.
How many FDA Form 483s has Caraco Pharmaceutical Laboratories, Ltd. received?
FDA Intel has 4 Form 483s on file for Caraco Pharmaceutical Laboratories, Ltd.; the most recent is dated May 30, 2020.
When was Caraco Pharmaceutical Laboratories, Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Caraco Pharmaceutical Laboratories, Ltd. is a Form 483 dated May 30, 2020, for the site in Detroit, Michigan.
What did FDA cite at Caraco Pharmaceutical Laboratories, Ltd.?
The regulations cited most in the observations on file for Caraco Pharmaceutical Laboratories, Ltd. are 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 4 times.