perrigo florida inc – FDA 483, Jul 22, 2005

An FDA inspection of Unico Holdings, Inc., an OTC drug, cosmetic, and medical food manufacturer, was conducted from July 19 to July 22, 2005. The inspection revealed several significant deviations from regulatory requirements, primarily concerning quality control, production, and material management practices.Key violations included the firm's failure to use stability testing results to establish expiration dates for products like "Vagi.Gard Povidone-Iodine Medicated Douche Concentrate." The Quality Control Unit's review of production and control records was found inadequate, with raw materials being released before complete testing results were available and documentation containing incorrect dates.Production system observations highlighted a lack of contemporaneous documentation for procedures, with discrepancies noted in batch records where second-person verification occurred when the verifying individual was not present. Additionally, the company lacked detailed written procedures for the approval and tracking of components, especially those under "Conditional Approval."Regarding the materials system, drug products and raw materials were not stored under appropriate, controlled conditions, evidenced by an uncontrolled warehouse temperature of 98°F. Unico Holdings, Inc. is required to address these observations to ensure compliance with current Good Manufacturing Practices (cGMP) and maintain product quality, strength, and purity.