Oy Finnsusp Ab – FDA 483, Apr 3, 2023

Oy Finnsusp Ab, an OTC drug manufacturer in Lieto, Finland, was inspected and cited for significant deficiencies across multiple systems. Observations included inadequate batch production records, failure to prevent contamination in the water system, deficient OOS investigations, and issues with reserve sample management. Additionally, the firm failed to follow procedures for preventing microbiological contamination in sterile drug production and lacked equivalent visual inspection procedures.