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Medical Devices / Submissions and Approvals

Illinois Devicemaker Slapped for Design Validation

June 4, 2019

The FDA hit HealthDent’l with a Form 483 after a Dec. 6-13 inspection revealed a lack of validation for its Class 2 non-sterile Hema-Benz dental desensitizer product.

The Plainfield, Illinois company’s device master record for the product contained a risk analysis noting that storage conditions of 77 degrees Fahrenheit or higher negatively impact its effectiveness.

However, the company was unable to provide a study or validation to demonstrate its shipping methods took temperature variations into account for the product.

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