FDA 483 - Wittman Pharma Inc - March 15, 2024

An FDA inspection of Wittman Pharma Inc., a drug manufacturer in Brooksville, FL, took place from February 6 to March 15, 2024. The inspection identified significant and often repeated violations of manufacturing quality standards. Key issues included a profound failure within the quality control unit, which lacked independence, proper procedures, and personnel with adequate manufacturing practice knowledge, leading to the release of over-the-counter (OTC) drug products without ensuring they met specifications. The firm also failed to establish effective microbial controls for its purified water system, despite persistent contamination with objectionable organisms like Burkholderia cepacia, Escherichia coli, and Pseudomonas aeruginosa, which was subsequently used in liquid OTC products, including those intended for children. Additionally, Wittman Pharma Inc. released products without completing finished testing, exhibited inadequate laboratory controls (including microbial suitability testing, proper sampling, and hold time studies), had incomplete equipment cleaning validation, and failed to adequately test raw materials, relying instead on unqualified supplier data. These observations indicate a widespread breakdown in critical quality and manufacturing processes, necessitating comprehensive corrective actions to ensure product quality and consumer safety.