Beckman Coulter, Inc. – FDA 483, Nov 13, 2009

An FDA inspection conducted at Stiefel Laboratories, Inc. in Research Triangle Park, NC, from October 26 to November 13, 2009, revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations, as documented in an FDA Form 483. The primary concern was the repeated failure to establish and follow procedures preventing objectionable microorganisms in non-sterile drug products. Specifically, the firm identified Burkholderia cepacia contamination in numerous drug product lots, leading to recalls, yet continued manufacturing with a contaminated raw material water system. Further issues highlighted an inadequate quality control unit that failed to thoroughly investigate unexplained discrepancies and out-of-specification results, including the release of products like PanOxyl Bar 10% that failed content uniformity. The firm also did not routinely test each batch of drug product for objectionable microorganisms, such as Burkholderia cepacia. Equipment deficiencies included an improperly designed and maintained USP water system lacking validation and routine sanitization, and a failure to calibrate critical monitoring probes. Additionally, employee training in specific operations and cGMP, particularly for microbiologists regarding Burkholderia cepacia identification, was found to be insufficient. Stiefel Laboratories is required to implement comprehensive corrective actions to address these systemic issues and ensure compliance with regulatory standards.