FDA 483 - Mission Pharmacal Company - April 04, 2019

An FDA inspection of Mission Pharmacal Company in Boerne, TX, a drug manufacturer, identified two significant issues. The facility's buildings used for drug manufacturing were not maintained in a good state of repair, exhibiting rust, peeling paint, and other deficiencies. Additionally, the firm's laboratory records were found to be deficient due to a lack of accountability for raw data documented on analytical sheets.