FDA WARNING_LETTER - Baxter Biosciences - October 19, 2009

The FDA issued a Warning Letter to Baxter Healthcare Corporation following an inspection of its Lessines, Belgium facility from October 12-19, 2009. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) in the manufacture of Gammagard Liquid and Gammagard S/D intermediates, violating Section 501(a)(2)(B) of the FD&C Act, Section 351(a) of the PHS Act, and 21 CFR Part 601.

Key violations include: 1. **Incomplete Failure Investigations:** Recurrent clogging of filters in Gammagard Liquid production, attributed to (b)(4), was not adequately investigated. Approximately 107 lots experienced clogging since January 2008, with 106 for US distribution, and 78 shipped. Impacted lots were not placed on stability, and corrective actions were not implemented, with 42% of 2009 lots still experiencing clogging. 2. **Failure to Follow Procedures:** The company failed to follow SOP LE-09-FT03076 for initiating exception reports for filter replacement events, even after the procedure was revised to allow more filter changes. 3. **Production and Process Controls:** Validation of the Solvent/Detergent (S/D) viral inactivation step lacked data for effectiveness with (b)(4)