FDA 483 - Winder Laboratories, LLC - July 18, 2018

Winder Laboratories, LLC received a Form 483 citing significant deficiencies across its quality unit, laboratory controls, and manufacturing operations. Key issues include inadequate OOS/OOT investigations, poor data integrity practices, uncalibrated equipment, and unsanitary conditions with pest infestations. These findings indicate a systemic failure to adhere to cGMP requirements, potentially impacting drug product quality and purity.