K Klean dba West Agro – FDA 483, Jul 19, 2024

Zeco LLC, an OTC drug manufacturer in Chattanooga, TN, was inspected by the FDA from July 15-19, 2024. The inspection revealed critical deficiencies in adherence to current Good Manufacturing Practices (CGMP). Significant violations were identified within the quality system, where the company failed to establish written procedures and implement oversight for fundamental processes such as product approval/rejection, finished product release testing, batch record management, deviation control, change management, complaint handling, annual product reviews, and supplier qualification. The firm also lacked proper equipment and process validation, adequate staff training, and robust data integrity measures.

Additional issues included the materials system's failure to conduct specific identity testing on critical raw materials like glycerin (for impurities) and isopropyl alcohol, relying instead on unverified supplier certifications. Laboratory controls were insufficient, with a lack of established methods for microbial and assay testing of finished drug products (e.g., HAND-I-SAN, Rubbing Alcohol) and no stability testing program to support product shelf life. Furthermore, observations noted an improperly designed and unvalidated water system. To comply with regulatory standards, Zeco LLC must undertake comprehensive corrective actions to address these systemic quality, materials, laboratory, and facility control failures, ensuring the safety and quality of its drug products.