FDA 483 - Ceva Animal Health - November 09, 2018

Ceva Animal Health, LLC in Oldsmar, FL, was cited for significant quality system deficiencies during an FDA inspection from November 7-9, 2018. The firm failed to adequately investigate unexplained discrepancies, out-of-specification results, and complaints, often lacking conclusions, follow-up, risk assessments, and corrective actions. Additionally, the company did not perform required annual product reviews for its drug products.