FDA 483 - HMS Veterinary Development Inc - November 07, 2014

HMS Veterinary Development Inc, a non-clinical GLP testing facility in Tulare, CA, was cited for significant deficiencies in its Quality Assurance Unit (QAU) during an FDA inspection. The observations highlight a lack of independence within the QAU, failure to adequately review final study reports and raw data, and insufficient monitoring of studies to ensure compliance with GLP regulations. These issues indicate a systemic breakdown in the firm's quality assurance processes for GLP studies.