FDA WARNING_LETTER - Reese Pharmaceutical Company - November 24, 2010

This FDA Warning Letter (CIN-11-160272-16) was issued to Reese Pharmaceutical Company following a November 3-24, 2010 inspection, identifying significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals (21 CFR Parts 210 and 211). These violations render drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's December 10, 2010 response was deemed inadequate.

Key violations include: 1. **Inadequate Investigations (21 CFR § 211.192):** Failure to thoroughly investigate a mislabeling incident where cold decongestant tablets were labeled as cough expectorant (Lot 091612). The firm failed to identify a root cause, provide rationale for the expectorant product not being at risk, and define an "unaccounted" category in reconciliation. Employee training on revised SOPs "A11-Inspection of Finished Product" and "A16-Custom Imprint Tracking Form" was also not addressed. 2. **Lack of Labeling Control (21 CFR § 211.125(a)):** Issuing various labels weeks in advance and storing them in uncontrolled open boxes, increasing mix-up risk. The firm's proposed tracking form was