FDA 483 - Eco Lips, Inc. - April 29, 2026
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Eco Lips, Inc. in Cedar Rapids, IA, was inspected and cited for significant quality control unit deficiencies. The firm failed to ensure the effectiveness of its corrective and preventive actions, leading to recurring documentation, batch record, and labeling errors, which culminated in two voluntary recalls of lip balm products. Additionally, the firm's procedures for auditing Active Pharmaceutical Ingredient (API) manufacturers were inadequate, and no formal audits had been conducted.
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ID · f2d2d155-aed7-49c2-bbd2-aab5d90962a1