FDA 483 - Guy & O'Neill Inc. - October 29, 2021

An FDA inspection of Guy & O'Neill Inc. in Fredonia, WI, a manufacturer of personal lubricant, revealed significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for corrective and preventive actions, control of nonconforming products, process validation, storage area control, and internal quality audits. Several observations were repeats from a previous inspection, indicating persistent and systemic issues.