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The QMN Weekly Bulletin

FDA Faults Dental Implant Manufacturer

Aug. 18, 2017

The FDA cited a Florida manufacturer of dental implants for numerous GMP and other deficiencies uncovered in a spring inspection.

The inspection of the Intra-Lock International facility in Boca Raton revealed problems with complaint evaluations, product standards, corrective actions, design changes, and assuring supplies received by the company were up to snuff.

The FDA pointed to the firm’s failure to thoroughly follow up on a report from a member of its sales team that a wrong screw had been included in the packaging for one product.

The agency also observed a problem with package sealing, and the firm’s failure to document and validate a change in cap size adopted in response to the issue.

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