FDA EIR - Weeks & Leo Co Inc - March 29, 2018

From March 26-29, 2018, the FDA conducted a comprehensive surveillance inspection of Weeks & Leo Co Inc., a manufacturer and repacker of dietary supplements, cosmetics, and other regulated products, primarily focusing on dietary supplement Good Manufacturing Practices (GMPs). The inspection revealed nine significant observations documented on an FDA Form 483 issued to the Chief Operating Officer. Key issues included inadequate cleaning and sanitization procedures for manufacturing and packaging equipment, with insufficient cleaning validation, particularly for shared equipment and items handling allergenic dietary supplements, raising concerns about cross-contamination. The company also failed to establish proper specifications for incoming dietary supplement products to ensure identification and consistency with purchase orders. Furthermore, deficiencies were noted in Master Manufacturing Records (MMRs), which lacked essential controls, sampling procedures, critical process specifications, and comprehensive labeling documentation. Batch Production Records (BPRs) were incomplete, missing dates for manufacturing steps and equipment maintenance logs. Finally, the firm lacked effective measures to prevent foreign material inclusion in dietary supplements. Management was encouraged to provide a written response within fifteen working days and was informed of the firm's responsibility for compliance with the Federal Food, Drug, and Cosmetic Act, along with potential penalties for non-compliance.