Dentlight Inc

FDA 483 - Dentlight Inc

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Record Details

An FDA inspection of Dentlight, Inc., a device manufacturer in Plano, TX, revealed two significant observations. The firm's internal quality audits were conducted by an individual directly responsible for the audited matters, and change records for controlled documents lacked descriptions of the changes and their effective dates.

Company: Dentlight Inc
Product Type: Device
Office: Dallas District Office
Person: Gilbert Valdez (investigator)

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ID · b3ab6acb-ff47-4dee-9bec-705b92ed6285