FDA 483 - Tedor Pharma, Inc. - June 05, 2025

Tedor Pharma, Inc. in Cumberland, RI, a drug product manufacturer, was cited for two observations during an FDA inspection. The firm failed to establish scientifically sound specifications for laboratory controls, specifically regarding reagent water quality, and did not investigate out-of-specification total organic carbon levels. Additionally, the inspection revealed a lack of documented employee training for critical operations, with a QC Chemist performing a key water testing method without proper training.