FDA EIR - Mission Pharmacal Company - September 20, 2018

The FDA conducted an inspection of Mission Pharmacal Co. in Boerne, TX, from September 19-20, 2018. This routine inspection, focusing on the manufacturing of dietary supplements, was carried out under specific FDA operational guidelines and in accordance with 21 CFR Part 111, which governs Current Good Manufacturing Practice for dietary supplements. During the comprehensive review, the investigator examined various aspects of the firm's operations, including production and process control systems, consumer complaints, product recalls, training records, shipping and raw material records, specifications, and equipment cleaning protocols. The inspection also involved a detailed review of product-specific records for Citracal Petites and Citracal Slow Release dietary supplements, including five batch production records for each, master manufacturing records, and deviation reports. Crucially, the inspection concluded with no observed deficiencies. Consequently, an FDA Form 483, typically issued to document objectionable conditions, was not issued to Mission Pharmacal Co. This indicates that the company was found to be operating in compliance with the relevant regulatory requirements for dietary supplement manufacturing at the time of the inspection. No specific corrective actions were required by the FDA following this inspection.