FDA 483 - HMS Veterinary Development Inc - March 04, 2022

HMS Veterinary Development Inc. in Tulare, CA, a non-clinical management facility, received a Form FDA 483 with 14 observations during an inspection from February 22 to March 4, 2022. The observations primarily highlight significant deficiencies in study data recording, final report completeness, personnel qualifications and training, adherence to protocols and SOPs, equipment calibration, and the independence and oversight functions of the quality assurance unit. These issues indicate a systemic lack of control over GLP-compliant nonclinical laboratory studies.