FDA EIR - Mission Pharmacal Company - April 04, 2019

An FDA pre-approval inspection of Mission Pharmacal Company in Boerne, TX, took place from April 1 to April 4, 2019. The inspection focused on the company's ability to manufacture Thiola® Enteric Coated Tablets (100mg and 300mg) under a new drug application (NDA 211843), specifically reviewing its Quality, Production, and Laboratory Control Systems. The inspection identified two significant observations documented on an FDA Form 483. First, the facility buildings used for drug product manufacturing, processing, packing, and holding were not maintained in a good state of repair, as evidenced by rust, peeling paint, unflush ceiling tiles, and flaking floor parts in various manufacturing areas. This violated 21 CFR 211.58. Second, laboratory records were found to be deficient, with raw data documented on uncontrolled, unnumbered "Miscellaneous Testing Test Sheets" lacking proper accountability, contradicting 21 CFR 211.194(a)(4). Additional concerns included incomplete process and cleaning validation for the new Thiola® EC tablets, absence of bulk hold time studies for intermediate products, and unidentified peaks in dissolution testing. Mission Pharmacal management acknowledged the findings and committed to providing a written response to the FDA 483 within 15 business days, outlining corrective actions. The FDA underscored that failure to rectify these issues could lead to sanctions, including a Warning Letter and potential disapproval of pending applications.