FDA EIR - Corden Pharma Colorado, Inc. - February 06, 2019

An FDA inspection of Corden Pharma Colorado, Inc., a manufacturer of pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs), was conducted from January 30 to February 6, 2019. The comprehensive inspection, guided by Compliance Program 7356.002F and ICH Q7 Good Manufacturing Practice for APIs, covered quality, facilities, equipment, materials, production, and laboratory control systems. The primary violation, documented on a one-item FDA Form 483, concerned unjustified deviations from written test procedures, specifically regarding microbiological media. The company was found not to be adequately ensuring the suitability of media plates used for microbial testing. This included a lack of consistent review of Certificates of Analysis upon receipt and insufficient growth promotion testing for each lot of media, which is crucial for confirming its ability to support microorganism growth and prevent inaccurate test results, reflecting principles outlined in 21 CFR 211.160(d). In addition, a discussion item highlighted concerns about the firm's water system, specifically the lack of routine testing for a critical mechanism designed to discard out-of-specification water. Corden Pharma management acknowledged the findings, committing to a written response to the agency within 15 business days. Immediate corrective actions included reviewing all outstanding media Certificates of Analysis, implementing procedural changes for future COA review, updating relevant Standard Operating Procedures, and initiating a work order to incorporate routine testing of the water system mechanism into their requalification plans.