FDA WARNING_LETTER - Kirk Pharmaceuticals, LLC - July 02, 2009

This Warning Letter, issued by the FDA to Kirk Pharmaceuticals, LLC on February 4, 2010, details significant Current Good Manufacturing Practice (CGMP) violations observed during a June 17-July 2, 2009 inspection. These violations render the firm's drug products adulterated.

Key violations include: 1. **Failure to reject out-of-specification (OOS) drug products:** Isoxsuprine Hydrochloride 20 mg tablets, lot (b)(4), with an OOS assay result, were released for distribution. The firm's investigation was deemed inadequate. 2. **Inadequate investigation of failures:** * Failure to investigate dissolution failures for Ephedrine Hydrochloride 12.5 mg/Guaifenesin 200 mg hard gelatin capsules validation lots. * Untimely investigation of blend uniformity failures for Diphenhydramine Hydrochloride 25 mg blend lots (b)(4) and (b)(4). * Inadequate investigations of dissolution failures for Diphenhydramine Hydrochloride 25 mg capsules at accelerated stability conditions, and discontinuation of studies without justification. * Failure to extend an investigation of an assay failure for Diphenhydramine Hydrochloride 25 mg capsules, lot (b)(4), to all distributed sub-lots. This is a repeat observation. 3. **Unvalidated test methods:** The