FDA 483 - Eco Lips, Inc. - March 31, 2021

Eco Lips Inc., an OTC Drug Manufacturer in Marion, IA, was inspected by the FDA from March 29-31, 2021. The inspection resulted in a Form FDA 483 citing several repeat observations indicating deficiencies in their manufacturing processes and quality systems, which are critical for compliance with the Federal Food, Drug, and Cosmetic Act. Key issues included a lack of appropriate stability data to support expiration dates for SPF lip balm products. The company also had deficient procedures for the annual quality standards record evaluation, specifically failing to review complaint, recall, and other relevant records for drug products containing active pharmaceutical ingredients. Furthermore, Eco Lips Inc. was behind on its planned internal audits. The inspection also revealed an absence of written procedures for production and process controls, with incomplete cleaning and process validation for their SPF 15 and SPF 30 lip balm products. Finally, the firm did not retain sufficient reserve samples of active ingredients from each manufactured batch of OTC lip balm, as required. Eco Lips Inc. is expected to address these observations to ensure its drug products meet established identity, strength, quality, and purity standards.