FDA 483 - Winder Laboratories, LLC - March 13, 2020

Winder Laboratories, LLC, a drug manufacturer in Winder, GA, was cited for significant deficiencies during an FDA inspection from March 9-13, 2020. Observations included inadequate design and control of the purified water system, failure to microbiologically test components, insufficient investigations into water failures and out-of-specification results, and deficient complaint handling. These issues indicate a lack of robust quality control and investigation processes.