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

Source: https://www.keypedia.com/records/warning_letter/kirk-pharmaceuticals-llc/6ed74e75-c426-455c-bff5-ba882c6dd53f

> FDA WARNING_LETTER for Kirk Pharmaceuticals, LLC on July 02, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Kirk Pharmaceuticals, LLC
- Inspection Date: 2009-07-02
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: 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

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Company: https://www.keypedia.com/companies/kirk-pharmaceuticals-llc/4fe9a62d-0dde-48df-9020-0570568c28a3

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9