FDA 483 - Bryant Ranch Prepack, Inc. - November 18, 2019

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals, a drug product repackager in Burbank, CA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning, maintenance, and qualification of equipment, as well as incomplete and poorly documented investigations into customer complaints and batch failures. Additionally, the firm failed to follow its own procedures for annual product quality reviews, indicating systemic issues in quality control.