HealthDent'l LLCDecember 13, 2018

FDA 483 - HealthDent'l LLC - December 13, 2018

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Record Details

HealthDent'l LLC, a medical device manufacturer in Plainfield, IL, received one observation during an FDA inspection. The firm failed to document the results of design validation, specifically concerning the impact of shipping temperature variations on the effectiveness of their Hema-Benz dental desensitizer. This indicates a significant lapse in quality system documentation for product design and distribution.

Company: HealthDent'l LLC
Inspection Date: December 13, 2018
Product Type: Device
Office: Chicago District Office
Person: Amanda Dinaro (investigator)

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ID · 102a5cd0-6530-4916-84e2-5a3a8ad6aa2c