Caraco Pharmaceutical Laboratories, Ltd.
Form 483 issued March 16, 2009 · Detroit, Michigan
- Inspection
- Mar 16, 2009
- Investigators
- Daniel J. Brown· L'oreal D. Fowlkes· Patsy J. Domingo
- Observations
- 16
- Pages
- 14
- FEI number
- 1833173
In short: On March 16, 2009, FDA issued a Form 483 with 16 observations to Caraco Pharmaceutical Laboratories, Ltd. in Detroit, Michigan (FEI 1833173) after an inspection that ran Mar 16, 2009. The investigators were Daniel J. Brown, L'oreal D. Fowlkes and Patsy J. Domingo. 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 11 of 16 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
Records fail to include an individual inventory record of each reconciliation of the use of each…
- 02
Written procedures are not followed for the storage…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 06
Written production and process control procedures are not followed in the execution of…
This inspection in context
Daniel J. Brown
1 document · 2009
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 16 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.?
Daniel J. Brown, L'oreal D. Fowlkes and Patsy J. Domingo are named on this Form 483, for the inspection of Mar 16, 2009. Each investigator has a profile showing what they cite most.
When was Caraco Pharmaceutical Laboratories, Ltd. inspected by FDA?
The inspection ran Mar 16, 2009, and the Form 483 is dated March 16, 2009.
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.