FDA EIR - Mission Pharmacal Co - February 23, 2018

This Establishment Inspection Report details a limited Food Good Manufacturing Practice (GMP) inspection of Mission Pharmacal Co. in San Antonio, TX, conducted on August 10, 2016. The inspection, carried out under regulatory framework CP 7303.803, focused on the firm's operations as a food manufacturer, dietary supplement manufacturer, and medical device kit assembler. However, a comprehensive dietary supplement GMP inspection was not performed during this visit. During the inspection, no new samples were collected, and no refusals were encountered. A significant finding noted was that corrections to observations documented on FDA Form 482 from a previous inspection were not verified. The previous inspection had been classified as "Voluntary Action Indicated" (VAI) under CP 7321.006, highlighting past compliance issues. The lack of verification was attributed to the differing regulatory scopes of the current limited inspection and the prior, broader assessment. Mission Pharmacal Co. produces two dietary supplements, "Calcet Citrate" and "Compete Energy Bites," in addition to operating a print shop and assembling medical device kits for its parent company. No significant changes from the last inspection were reported. All post-inspectional correspondence should be directed to Juan H. Tays, Diagnostics and Devices Manager.