483
Dentlight IncFDA 483 - Dentlight Inc - August 23, 2023
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Record Details
An FDA inspection of Dentlight Inc in Plano, TX, revealed a significant quality system deficiency. The firm's internal quality audits were conducted by individuals who had direct responsibility for the matters being audited, compromising the independence of the audit process. This indicates a lack of proper controls for ensuring objective quality assessments.
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