Eco Lips Inc – FDA 483, Mar 24, 2022

An FDA inspection conducted from March 22-24, 2022, identified significant deficiencies at a firm manufacturing SPF products. The FDA Form 483 report highlighted multiple areas where the company failed to meet essential Good Manufacturing Practices (GMP) across its laboratory, production, and quality systems. Key issues in the laboratory control system included inadequate stability testing, with only a single batch tested for some SPF lip balm products, and the absence of a written program for both initial and ongoing stability studies. Furthermore, computer controls were found to be insufficient, allowing unauthorized data modifications and lacking unique user authentication for laboratory instruments. Within the production system, the firm lacked crucial written procedures for process controls, with process validation incomplete for the majority of SPF product groups. Cleaning validation for manufacturing equipment, including kettles and filling machines, was either incomplete or not yet established. The quality system also exhibited shortcomings, including a failure to conduct annual quality reviews for most drug product groupings. Investigations into product complaints and out-of-specification results were found to be deficient, lacking critical details such as quality reviews, personnel interviews, and comprehensive follow-up. To achieve compliance, the firm must implement robust stability programs, establish comprehensive written procedures for all manufacturing and control processes, ensure data integrity, complete all necessary validations, perform annual product quality reviews, and enhance its investigation protocols.