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

Eco Lips Inc, an OTC drug manufacturer in Marion, IA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including a lack of stability data for SPF lip balms, inadequate annual quality record evaluations, and incomplete cleaning and process validation. Additionally, the firm failed to retain sufficient reserve samples of active ingredients.