FDA 483 - Ceva Animal Health - November 09, 2018

An FDA inspection conducted at Ceva Animal Health, LLC, located in Oldsmar, FL, from November 7-9, 2018, resulted in a Form FDA 483 citing significant quality system deficiencies. The report identified two primary observations related to the company's handling of product quality and regulatory compliance, under the framework of the Federal Food, Drug, and Cosmetic Act. The first major observation highlighted that written records of investigations into unexplained discrepancies and product failures to meet specifications consistently lacked complete conclusions and follow-up actions. Specifically, the firm failed to adequately investigate numerous complaints regarding texture inconsistencies and out-of-specification results for active ingredients, including instances where distributed products were not subject to risk assessment or corrective actions. Several complaints concerning mislabeled products also lacked proper root cause investigations and implementation of corrective and preventative actions. Furthermore, multiple quality investigations remained open without follow-up or resolution regarding potential root causes or preventative measures. The second observation noted the absence of established and followed written procedures for annual product evaluations. Ceva Animal Health, LLC failed to conduct required annual product reviews for all 21 of its drug products, which should include a comprehensive review of complaints, recalls, returned products, and conducted investigations. These observations indicate a clear need for the company to strengthen its quality management system, ensuring thorough investigations, effective corrective actions for distributed products, and diligent oversight through routine product evaluations to comply with regulatory expectations.