483
TRUECARE BIOMEDIXTRUECARE BIOMEDIX – FDA 483, Feb 21, 2025
Record Details
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.
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ID · 82bded1b-736e-4b5c-8008-e3028c9d0450
Violation Codes2
21 U.S.C. 374(b)FD&C Act 704(b)
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