Caraco Pharmaceutical Laboratories, Ltd.
Form 483 issued June 11, 2008 · Detroit, Michigan
- Inspection
- May 1 – Jun 11, 2008
- Investigators
- Andrea F. White· Caroline H. Le· Patsy J. Domingo
- Observations
- 14
- Pages
- 9
- FEI number
- 1833173
In short: On June 11, 2008, FDA issued a Form 483 with 14 observations to Caraco Pharmaceutical Laboratories, Ltd. in Detroit, Michigan (FEI 1833173) after an inspection that ran May 1 – Jun 11, 2008. The investigators were Andrea F. White, Caroline H. Le, Patsy J. Domingo, Rebecca E. Dombrowski, Regina Brown and Tracey L. Taylor. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 10 of 14 observations.
Most cited: 21 CFR 211.192 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Andrea F. White
1 document · 2008
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
The firmCaraco Pharmaceutical Laboratories, Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Caraco Pharmaceutical Laboratories, Ltd.?
FDA listed 14 observations on this Form 483, mostly about quality system, production and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Caraco Pharmaceutical Laboratories, Ltd.?
Andrea F. White, Caroline H. Le, Patsy J. Domingo, Rebecca E. Dombrowski, Regina Brown and Tracey L. Taylor are named on this Form 483, for the inspection of May 1 – Jun 11, 2008. Each investigator has a profile showing what they cite most.
When was Caraco Pharmaceutical Laboratories, Ltd. inspected by FDA?
The inspection ran May 1 – Jun 11, 2008, and the Form 483 is dated June 11, 2008.
How do I get the full Form 483 for Caraco Pharmaceutical Laboratories, Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.