FDA Consent Decree with Accurate Set

Dental product maker Accurate Set (Newark, NJ) and FDA have entered into a consent decree of permanent injunction that is intended to shut down the company until the agency clears or approves its products.

The decree, which personally names company owner Cornell L. Adams as a defendant, also requires the company to comply with FDA's quality standards in any future manufacturing of restorative dental products such as dental impression and repair materials. Accurate Set and owner Adams have told FDA they are no longer manufacturing or distributing any devices.
The decree follows an inspection of the firm ending in January of 2011 that “revealed significant violations of the FDA’s Quality System (QS) regulation, including violations related to the firm’s corrective action and consumer complaint procedures, purchasing controls, and quality audits,” according to the agency. Investigators also found that the firm’s medical devices, such as Setacure Self Curing Polymer and Self Cure Tooth Shade Acrylic, had not undergone required FDA premarket review.

A warning letter in 2010 noted that the firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA). Also, Its complaint record for the heat cure acrylic did not include information to show whether an investigation was conducted, what caused the material to not set properly, and whether any CAPA was implemented as required by the firm’s written procedure for handling complaints. Quality audits were also not conducted at sufficient regular intervals, as prescribed by the firm’s internal audit procedure, it said.