FDA 483 - Woodbine Products Company - September 01, 2022

Woodbine Products Co Inc, an OTC drug manufacturer in Medina, OH, was cited for significant deficiencies in its quality control unit, including failure to test finished products and a lack of written procedures for critical operations. The inspection revealed insanitary conditions, inadequate raw material identity testing, and a complete absence of stability studies to support product expiration dates. These issues indicate a severe lack of control over drug product quality and manufacturing processes.