FDA EIR - Mission Pharmacal Company - May 04, 2017

An FDA inspection of Mission Pharmacal Co. in Boerne, TX, was conducted from May 1 to May 4, 2017. This surveillance inspection focused on post-marketing adverse drug experiences and evaluated the firm's Quality and Laboratory Control systems for prescription/OTC drug products, dietary supplements, and medical devices. Overall, no significant deficiencies were observed, and no FDA-483 (Inspectional Observations) was issued. The inspection confirmed that a blend uniformity testing deficiency noted in a previous 2014 inspection had been corrected. However, during the review of dietary supplement operations under 21 CFR 111 (Current Good Manufacturing Practice), two matters were discussed with management. First, the website for Calcet Petites, a dietary supplement, contained impermissible disease claims, specifically mentioning "treatment of osteoporosis." Second, the firm initially struggled to provide raw material receiving records for folic acid within the required retention period, highlighting a need for improved document accessibility. In response, Mission Pharmacal Co. management promptly initiated revisions to the website to remove the inappropriate claims and committed to updating their record retention procedures to ensure documents are readily available as required by regulations.