FDA Criticism of Equipment Maintenance Under 21 CFR 211.67(a)

A Canadian drug manufacturer, Apotex Inc., received an FDA warning letter for violations of 21 CFR 211.67(a) related to inadequate equipment cleaning and maintenance. Inspectors found white particulate deposits on machinery used to produce spray drug products, along with particles on a conveyor belt for closure components. Although the company had purchased improved equipment nearly a year earlier, it continued using older units that generated particles, revealing a deficient maintenance programme. The FDA criticised this failure to prevent contamination risks and highlighted the need for an “effective equipment management programme,” representing a proactive life cycle approach beyond basic GMP requirements. This includes continuous monitoring, timely maintenance, and prompt replacement to protect process capability. The agency now expects a comprehensive, independent review of cleaning effectiveness, identification of residues, assessment of potentially affected equipment, and evaluation of cross-contamination risks across all multi-product facilities.

10-12-2025