FDA 483 - Libby Laboratories, Inc. - March 14, 2025

Libby Laboratories, Inc. in Berkeley, CA, a drug manufacturer, was cited for significant deficiencies in its quality control systems during an FDA inspection. Observations included failures to adequately test and release raw materials, perform identification tests for components, and establish the reliability of Certificates of Analysis. Additionally, the firm failed to test finished non-sterile drug products for objectionable microorganisms over the past two years.