FDA 483 - Seaway Pharma Inc. - July 24, 2024

Seaway Pharma Inc. received an FDA Form 483 following an inspection conducted on July 24, 2024, at their Massena, NY facility. The inspection identified one significant observation regarding the firm's physical plant plumbing systems. Specifically, the plumbing design was found to allow potential cross-connections between systems discharging waste water or sewage and those carrying water used for manufacturing dietary supplements, cleaning contact surfaces, or supplying hand-washing facilities. A concrete example noted was a non-functioning employee break room sink with a leaking faucet and no hot water. This condition raises concerns under Section 704(b) of the Federal Food, Drug and Cosmetic Act, which addresses situations where products could be prepared or held under insanitary conditions, potentially leading to contamination or harm. Chirag Ghodakiya, the Quality Assurance Manager, assured the investigator that the issue would be reported to maintenance for repair. Seaway Pharma Inc. is expected to promptly implement corrective actions to address these plumbing deficiencies and ensure the integrity and safety of its manufacturing environment.