Winder Laboratories, LLC – FDA Warning Letter, Jul 18, 2018

The FDA inspected Winder Laboratories, LLC, from July 9-18, 2018, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated. Key deficiencies included the firm's failure to establish adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b)), with unvalidated cleaning processes and observed residue on "clean" equipment. Laboratory records were incomplete (21 CFR 211.194(a)), showing uninvestigated audit trail anomalies like "run single injection" and "delete result set" messages. The firm also lacked adequate written procedures for production and process control (21 CFR 211.100(a)), evidenced by missing equipment qualification records, insufficient calibration for relocated equipment, and an inadequate water system design with poor monitoring. Additional concerns involved deficient Out-of-Specification (OOS) investigations, such as retesting without proper Phase I investigation, failure to follow OOS SOPs, and neglecting to investigate leaking stability samples. A systemic data integrity issue was noted, indicating the quality system's failure to ensure data accuracy. The FDA strongly recommended engaging a qualified CGMP consultant. The firm must promptly correct all violations, provide a written response within 15 working days detailing corrective and preventive actions, and address specific requests regarding cleaning validation, data integrity investigation, risk assessment, and a management strategy. Failure to comply may result in legal action, withholding of drug application approvals, and other severe business implications.