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Talk to a SpecialistTalk to a SpecialistEco Lips, Inc., a drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations related to its over-the-counter drug products, rendering them adulterated. The company failed to establish an adequate stability testing program and did not provide sufficient data to support the expiration dates assigned to its product groupings, with multiple products failing to meet chemical and physical specifications at various timepoints during accelerated stability testing, including failures in assay and color specifications. The violations were documented during an FDA inspection conducted in March 2022 at the facility in Cedar Rapids, Iowa.