FDA WARNING_LETTER - Wittman Pharma, Inc. - March 15, 2024

The FDA inspected Wittman Pharma, Inc. from February 6 to March 15, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm's quality control unit failed to ensure CGMP compliance and meet specifications, approving drug products for release without complete finished product testing, and lacking adequate authority, as senior management circumvented their decisions.

Wittman Pharma also failed to establish adequate written procedures for production and process control. Their water system, used as a component in drug products, was not adequately qualified, showing objectionable microorganisms like *Burkholderia cepacia* and other excursions, yet drug products were manufactured and released. Furthermore, the firm failed to conduct identity testing for each shipment of each lot of propylene glycol, a high-risk component for diethylene glycol (DEG) and ethylene glycol (EG) contamination.

The FDA recommends engaging a qualified consultant to evaluate operations and assist in meeting CGMP requirements, including a comprehensive six-system audit. The firm must respond in writing within 15 working days, detailing corrective actions and prevention plans. Failure to address these violations may result in regulatory action, including seizure, injunction, and withholding of export certificates or new application approvals.