FDA 483 - Eco Lips, Inc. - March 24, 2022

During an inspection, Eco Lips Inc. was cited for multiple deficiencies related to quality control and manufacturing processes for their SPF lip balm products. Observations included inadequate stability testing, lack of written stability programs, insufficient computer system controls, and incomplete process and cleaning validations. The firm also failed to conduct annual product quality reviews and maintain complete investigation records for complaints and out-of-specification events.