FDA 483 - Seaway Pharma Inc. - September 21, 2023

Seaway Pharma Inc., a drug manufacturer in Massena, NY, was cited for numerous significant Current Good Manufacturing Practice deficiencies during an FDA inspection from August to September 2023. The observations highlight critical failures in component testing, quality systems, process validation, equipment cleaning and maintenance, environmental controls, and quality unit oversight, indicating a systemic lack of control over drug product manufacturing and release. These issues pose a serious risk to the identity, strength, purity, and quality of the drug products produced.