FDA 483 - Carecam International, Inc. - October 23, 2025

An FDA inspection of Carecam International, Inc., a drug repackager in Fairfield, NJ, revealed a significant deviation from written procedures for equipment cleaning and maintenance. Specifically, the firm failed to follow its own SOPs for partial cleaning of a packaging room, leading to the presence of previous batch materials and tablets on the floor. This indicates a lapse in maintaining sanitary conditions for drug product handling.