FDA 483 - Eco Lips, Inc. - September 25, 2019

Eco Lips Inc, a manufacturer of SPF lip balms and face creams in Marion, IA, received a Form 483 citing seven significant Good Manufacturing Practice deficiencies. The observations primarily highlight inadequate product testing for identity and strength, lack of validated cleaning processes, and insufficient stability data to support product expiration dates. Additionally, the firm was cited for deficiencies in complaint handling, annual product reviews, and record-keeping for theoretical yields and equipment cleaning verification.