perrigo florida inc – FDA 483, Feb 11, 2008

Unico Holdings, Inc., a manufacturer of medical foods and Over-The-Counter (OTC) drugs, underwent an FDA inspection from January 22 to February 11, 2008. The inspection, documented in a Form FDA 483, identified several critical issues concerning quality system compliance. The company failed to adhere to its own product recall policy for medical foods, specifically neglecting comprehensive follow-up actions for three lots (GR70774, GR70775, GR62459) recalled due to microbiological failures or contamination complaints. Only initial recall notifications were sent, with no further observed actions, marking this as a recurrent observation. Additionally, deficiencies were noted in the laboratory control system, where annual visual examinations of finished OTC drug product reserve samples for deterioration were not performed as mandated by internal procedures. Lastly, the firm lacked a written program for the routine calibration, inspection, and monitoring of critical equipment, specifically failing to assess or control its air handling and compressed air systems vital for manufacturing. Unico Holdings, Inc. is required to implement comprehensive corrective actions to address these deviations from regulatory expectations and internal procedures to ensure product quality and safety.