FDA 483 - Medisca, Inc. - November 20, 2025

An FDA inspection of Medisca, Inc. in Plattsburgh, NY, a drug substance repacker/relabeler, revealed seven significant observations. These findings primarily concern inadequate calibration and cleaning procedures for hazardous drug repackaging equipment, inappropriate personnel gowning, and failures in preventing contamination during material handling. Additionally, the firm lacked proper component testing for excipients, failed to validate and document container closure integrity, and maintained production environments with contamination risks.