FDA EIR - Weeks & Leo Co Inc - April 07, 2022

A comprehensive surveillance inspection of Weeks and Leo Co., Inc., a human drug manufacturer and contract re-packer located in Clive, IA, was conducted by the FDA from April 4 to April 7, 2022. The inspection, performed under regulatory guidelines for drug manufacturing and repackaging (CP 7356.002 and CP 7356.002B), revealed significant deficiencies, resulting in a six-item FDA Form 483. Key violations included a repeated failure to thoroughly investigate unexplained discrepancies and batch failures. Specific issues highlighted inadequate investigations into leaking product containers and multiple consumer complaints reporting severe burning sensations from a Capsaicin product, with several adverse events not properly investigated. The company also failed to establish appropriate controls over computer systems to ensure authorized changes, and its laboratory controls lacked scientifically sound specifications and testing procedures for raw materials like glycerin (for diethylene glycol) and alcohol (for methanol), as well as for water systems. Deficient complaint records, often missing adverse event determinations and investigation findings, were noted. Additionally, time limits for production phases were not established, leading to product and materials being held for extended periods. Discussions with management also addressed issues with inadequate storage and retention of reserve samples and the co-mingling of quarantined and released products. These observations indicate a need for the company to implement comprehensive corrective and preventative actions to achieve compliance with manufacturing quality standards.