IriSys, Inc. – FDA Warning Letter, Apr 1, 2010

On August 23, 2010, the FDA issued a Warning Letter to IriSys, Inc. following an inspection from March 16 to April 01, 2010, at their San Diego, CA pharmaceutical manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key CGMP violations included: 1. **Inadequate Production and Process Controls (21 CFR § 211.100(a)):** The firm lacked adequate written procedures for production and process controls. For example, during Donnatal Elixir process validation, equipment and process modifications (e.g., adjusting mixing times, changing raw material addition order) were made without adequate change control, preventing confirmation of the manufacturing process's capability. The firm's concurrent release strategy for batches during validation was deemed inadequate. 2. **Insufficient Component Specifications and Testing (21 CFR § 211.160(b)):** The firm failed to establish scientifically sound specifications and test procedures for components. Specifically, water used for final rinse during mixing tank cleaning for non-sterile liquid products was not tested to ensure it met purified water specifications. The firm did not