FDA 483 - TRUECARE BIOMEDIX - February 21, 2025

An FDA inspection of TrueCare Biomedix in Kalishore, India, revealed a significant issue with the firm's quality control unit. Specifically, the company's written procedures for good documentation practices were not consistently followed, leading to a lack of required signatures and dates in log books. This indicates a moderate severity concern regarding adherence to established quality control protocols.