FDA WARNING_LETTER - Winder Laboratories, LLC - August 05, 2025

The FDA issued a Warning Letter to Winder Laboratories, LLC, following an inspection of their Winder, Georgia drug manufacturing facility from July 14 to August 5, 2025. The letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues included the firm's failure to adequately clean and maintain manufacturing equipment. Investigators observed drug product residue, oxidized metal surfaces, and foreign material on "cleaned" equipment. This recurring issue was also cited in previous inspections and is potentially linked to a voluntary recall of tablets containing an incorrect product. Furthermore, essential metal detection equipment was found to be non-functioning, and its qualification was incomplete, leading to a metal screw being discovered in a sealed product bottle.

Additionally, the FDA cited failures in facility maintenance, observing structural deficiencies such as gaps in protective walls, unknown material accumulation, and improperly secured ceiling vents, which compromise the cleanliness and integrity of the manufacturing environment.

Winder Laboratories" responses were deemed inadequate as they lacked evidence of effective cleaning methods, a retrospective risk assessment for impacted products, and commitments for comprehensive equipment requalification. The FDA requires a comprehensive, independent assessment of cleaning effectiveness, a corrective and preventive action plan, improvements to cleaning validation, updated standard operating procedures, and robust protocols for equipment and facility qualification.