Mission Pharmacal Company – FDA EIR, Feb 7, 2014

A compliance follow-up inspection of Mission Pharmacal Co. in Boerne, TX, was conducted by the FDA from January 27 to February 7, 2014. The inspection covered the manufacturing of prescription and OTC drug products, dietary supplements, and medical devices, operating under regulatory frameworks for abbreviated drug manufacturing, NDA field alert reporting, unapproved new drugs, postmarketing adverse drug experience reporting, and dietary supplements. This visit aimed to assess the company's corrective actions following a March 2012 inspection that resulted in an Official Action Indicated (OAI) classification and an Untitled Letter in May 2013. The primary observation during the current inspection was a repeat finding: the company's failure to conduct in-process blend uniformity testing for prenatal drug products. This specific issue had not been corrected for all current drug products since the previous inspection. Other prior violations included failures in submitting NDA Field Alerts, maintaining and conducting complete complaint investigations, adhering to quality control unit procedures, and conducting complete process validations. While most previous issues were reportedly addressed, the blend uniformity testing remained outstanding. The inspection focused on the Quality, Facilities and Equipment, Production, and Laboratory Control systems. Management acknowledged the new observation and committed to providing a written response to the FDA Dallas District Office within 15 business days. Discussions also included expanding complaint investigations, addressing minor housekeeping, ensuring quality assurance review of laboratory notebooks, and evaluating lab analyst performance.