FDA 483 - Professional Disposables International, Inc. - October 29, 2008

During an FDA inspection conducted from October 21-29, 2008, Professional Disposables International, Inc., a pharmaceutical manufacturer, was cited for several significant deviations from current Good Manufacturing Practices (cGMP). The inspection highlighted critical shortcomings in the company's quality management systems and operational procedures. Key issues included a systemic failure to thoroughly review unexplained discrepancies and batch failures. The firm lacked adequate written procedures for investigations, resulting in numerous non-conformance reports that did not sufficiently explain discrepancies, assess product impact, identify root causes, or define corrective actions. Furthermore, the company had not conducted or documented required annual product reviews for its drug products since 2005, contrary to its own standard operating procedures. Deficiencies were also noted in laboratory controls, where the procedure for handling Out-of-Specification (OOS) results allowed for invalidation of initial OOS findings with insufficient retesting and did not mandate documenting attempts to determine the assignable cause. Additionally, master production and control records lacked essential details, such as theoretical yield statements and the thresholds beyond which investigations are required. These observations necessitate immediate and comprehensive corrective actions from Professional Disposables International, Inc. to ensure adherence to regulatory standards and product quality.