FDA 483 - Best Formulations Inc - June 12, 2019

Best Formulations, Inc. in City Of Industry, CA, received a Form 483 with six observations related to significant deficiencies in their quality control and laboratory operations for animal drug manufacturing. The inspection revealed issues with drug product testing and release, inadequate computer system controls, insufficient OOS investigations, and poor control over laboratory documentation and instrument calibration. These findings indicate a lack of robust quality oversight and data integrity practices.