FDA 483 - Ceva Animal Health, LLC - February 04, 2013

Sogeval Laboratories, Inc., an own-label distributor of veterinary drugs in Irving, TX, was cited for significant deficiencies in its complaint handling and adverse event reporting systems. The inspection revealed incomplete investigations into human and animal adverse reactions, lacking proper root cause analysis and review of critical documentation. Additionally, the firm's procedures for managing complaints and adverse event trends were found to be inadequate, specifically regarding the definition and handling of product safety alerts.