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Seaway Pharma Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter oral liquid drug products for infants and children, including analgesics and cough/cold medications. The company's quality control unit failed to follow its own batch release procedures, releasing numerous drug product batches between April 2024 and May 2025 without reviewing all test results or verifying that active ingredient strength met specifications prior to distribution. Additionally, the firm did not establish adequate written responsibilities and procedures for quality control oversight, resulting in products that the FDA determined were adulterated. The inspection was conducted from May 19 to June 18, 2025, with the company providing a response on July 30, 2025.