Person & Covey Inc – FDA Warning Letter, Feb 6, 2025

The FDA issued a Warning Letter to Persōn & Covey, Inc. following an inspection from January 27 to February 6, 2025. The agency found significant violations of Current Good Manufacturing Practice (CGMP) regulations for drug products, deeming them adulterated. Additionally, Xerac AC and Drysol products were cited as unapproved new drugs introduced into interstate commerce, violating sections 501(a)(2)(B) and 505(a) of the Federal Food, Drug, and Cosmetic Act. Key violations centered on the company"s quality control unit failing to ensure drug products met specifications and CGMP requirements. Inspectors observed inadequate documentation and investigation of out-of-specification results, such as for Xerac AC, where initial failing tests were disregarded. Pervasive data integrity issues were identified, including shared laboratory system passwords, lack of formal data integrity procedures, and insufficient audit trail reviews, compromising the reliability of manufacturing data. Furthermore, the quality unit failed to provide adequate oversight, exemplified by the unauthorized and undocumented rework of a Solbar Zinc Sunscreen batch, circumventing established procedures and QA approval. The FDA requires Persōn & Covey, Inc. to conduct a comprehensive investigation into the extent and root causes of data inaccuracies, assess the associated risks to drug quality and patients, and implement a global corrective and preventive action plan to ensure the reliability and completeness of all generated data. The company must also submit a remediation plan to strengthen its quality unit"s authority and resources, ensuring robust procedures, effective oversight, thorough batch reviews, and proper investigation approvals.