U.S. Food and Drug Administration Cites Cleaning Failures at Winder Laboratories, LLC

In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) cited Winder Laboratories, LLC for violations of 21 CFR 211.67 concerning equipment cleaning and maintenance. Inspectors observed product residues and oxidized metal surfaces on a non-dedicated tablet press that Quality Assurance had already released as clean. Similar issues were found on dedicated equipment, including residues and foreign material.

The firm proposed enhanced visual inspections and additional training. However, the FDA determined this response was insufficient, noting the absence of validated cleaning procedures and a retrospective risk assessment covering products still within expiry.

The agency requested a comprehensive review of prior cleaning effectiveness, cross-contamination risks, and potentially affected batches, along with a robust CAPA plan. It also emphasized improved cleaning validation, including worst-case scenario evaluation, lifecycle vulnerability analysis, change management controls, and formal qualification procedures for equipment and premises.

27-02-2026