FDA 483 - PharmaLogic CSP, Inc. - December 12, 2014

During an inspection conducted from December 8-12, 2014, the FDA observed significant deficiencies at PharmaLogic CSP, Inc., an outsourcing facility. The inspection, guided by current Good Manufacturing Practices and specific requirements for 503B facilities, revealed several critical issues. Key observations included inadequate systems for cleaning and disinfecting aseptic processing areas, such as the absence of sporicidal agents and improper cleaning of critical equipment. Environmental monitoring was found to be deficient, lacking written procedures, specific sampling frequencies, and alert limits, with no personnel monitoring during routine production. The facility also failed to properly maintain equipment controlling aseptic conditions, evidenced by undocumented pressure differential reviews and no continuous monitoring. Furthermore, procedures designed to prevent microbiological contamination were not consistently followed during process validations, with incomplete documentation for media fills and a lack of proper controls. The firm did not use stability testing results to establish expiration dates for sterile drug products, and critical components like containers and closures were used without proper quality control release or Certificates of Analysis. Finally, several drug product labels lacked required information for outsourcing facilities, such as "This is a compounded drug," "Office Use Only," compounding date, and administration details. The company is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure regulatory compliance.