FDA WARNING_LETTER - Seaway Pharma Inc. - June 18, 2025

The FDA issued a Warning Letter to Seaway Pharma Inc. following an inspection of their drug manufacturing facility in Massena, NY, from May 19 to June 18, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products, particularly over-the-counter oral liquid medications for infants and children, adulterated.

Key issues identified include inadequate oversight by the Quality Control Unit (QU). The company failed to establish and follow written procedures, releasing numerous batches of drug products between April 2024 and May 2025 without fully reviewing all test results, including active ingredient strength and microbial testing, to ensure they met specifications. The FDA found the QU lacked sufficient resources and proper quality system controls.

Furthermore, Seaway Pharma Inc. failed to adequately test incoming drug components for identity, especially high-risk materials like glycerin and sorbitol solution, prior to their use in manufacturing. This is critical due to the potential for lethal diethylene glycol (DEG) or ethylene glycol (EG) contamination, despite the company"s assertion of no enforceable provisions (which the FDA refuted, citing USP standards enforceable under the FD&C Act).

Required actions include a comprehensive assessment and remediation plan for the QU to ensure its authority, resources, and robust oversight of all operations, including complete batch and component test result reviews before release. The company must also implement a rigorous program for testing all incoming components for identity, strength, quality, and purity, specifically including DEG/EG analysis for high-risk materials, and provide a commitment to ongoing quality unit review and approval.