FDA WARNING_LETTER - Abbey Color, Inc. - March 23, 2012

An FDA inspection of Abbey Color, Inc.'s active pharmaceutical ingredient (API) manufacturing facility, conducted from March 13-23, 2012, identified significant deviations from current Good Manufacturing Practice (CGMP). These deviations cause the firm's APIs to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The firm's response dated April 12, 2012, was deemed to lack sufficient corrective actions. Key violations included the failure to validate and monitor the water purification system to ensure appropriate quality, a repeat observation from a 2010 inspection, with continued out-of-specification (OOS) endotoxin and total organic carbon (TOC) results. The firm also failed to adequately investigate and document OOS test results, such as those for rinse water from equipment cleaning, indicating a lack of executive management oversight in identifying and remediating manufacturing control problems. Additionally, Abbey Color failed to establish an adequate stability program to monitor API characteristics and confirm storage conditions or retest/expiry dates, another repeat observation, with limited stability data and inadequate testing procedures. The FDA requires prompt corrective actions, including comprehensive gap analyses for the water system and OOS investigations, and a detailed stability program. The firm must respond within fifteen working days, outlining specific steps, timelines, and supporting documentation. Failure to comply may lead to legal action, including seizure and injunction, and impact federal contracts, export certificates, and drug application approvals. The FDA also requested contact with the Drug Shortages Program if production reductions are considered.