FDA 483 - Mission Pharmacal Company - May 25, 2012

Mission Pharmacal Co. in Boerne, TX, was cited for significant deficiencies in its quality system and production processes during an FDA inspection. The firm failed to submit NDA Field Alert Reports, maintain complete complaint records, and conduct thorough investigations into product failures. Additionally, issues were noted with process validation, including a lack of statistical rationale for sampling sites and inadequate in-process controls for blend uniformity.