FDA 483 - Caraco Pharmaceutical Laboratories, Ltd. - June 11, 2008

This FDA Form 483, issued to Caraco Pharmaceutical Laboratories, Ltd., a drug manufacturer located at 1150 Elijah McCoy Dr, Detroit, MI, details observations from an inspection conducted between May 1, 2008, and June 11, 2008. Daniel H. Movens, CEO, was the recipient.

The inspection revealed 14 observations related to quality system and manufacturing deficiencies:

1. **Inadequate Investigation of Discrepancies:** Failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. This includes uncompleted investigations into drug product contamination (Tramadol HCl 50 mg Tablets with an unknown contaminant, Metoprolol Tartrate 50mg Tablets with an unknown contaminant), content uniformity failures (Metoprolol Tartrate Tablets, 25 mg), dissolution test failures (Carbamazepine USP 200 mg tablets), and OOS for content uniformity (Tramadol HCl/Acetominophen 37.5/325 Tablet). Additionally, there was a lack of adequate investigation into raw material reconciliation failures (Tramadol Hydrochloride and Citalopram Hydrobromide).

2. **Limited Scope of Investigations:** Investigations into product cross-contamination incidents (Tramadol and Metoprolol lots) did not extend to all other drug product lots dispensed within the same timeframe (01/25-29/08).

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