FDA Hits Miami Devicemaker for Validation, Qualification

Dharma Research failed to validate its processes or to qualify equipment used for its dental gel, the FDA said following an inspection of the firm’s Miami, Florida facility.

The company failed to validate storage conditions for its Etchant gel prior to the final syringe packaging, and there was inadequate documentation of control methods, monitoring and data collection for the sealing of the prophylaxis paste cups, the agency said — noting this as a repeat observation from a previous inspection.

The FDA said the company’s production processes were not monitored to ensure that a device conformed to specifications.