FDA Criticizes Facility Maintenance Failures at Drug Manufacturer

The U.S. Food and Drug Administration has cited significant facility maintenance violations at Winder Laboratories, LLC, referencing requirements under 21 CFR 211.58. The regulation requires drug manufacturing buildings to be properly maintained to prevent contamination and ensure product quality.

During the inspection, the FDA observed several structural issues. Gaps in a protective wall in the machine room created areas that were difficult to clean. Inspectors also found brown-yellow residue in wall gaps near production equipment, raising potential contamination concerns. In addition, a ceiling vent in the tablet room had been temporarily secured with adhesive tape, and unfinished wall surfaces in another room made proper cleaning impossible.

The manufacturer stated it would halt production and implement corrective and preventive actions until repairs were completed. However, the FDA demanded a comprehensive CAPA plan, routine monitoring of facilities and equipment, documented repair evidence, and stronger management oversight. Similar issues had been noted in previous inspections.

04-03-2026