TRUECARE BIOMEDIXFebruary 21, 2025

FDA 483 - TRUECARE BIOMEDIX - February 21, 2025

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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.

Company: TRUECARE BIOMEDIX
Inspection Date: February 21, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Chad W. Rice (investigator)

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