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# China’s Implant Dental Technology Has QS Issues
- URL: https://www.fdaweb.com/chinas-implant-dental-technology-has-qs-issues/
- Published: 2017-02-07T12:00:00.000Z
- Updated: 2026-09-14T22:05:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137920

A 6/27-6/30/16 FDA inspection at Implant Dental Technology, Guangdong, China, found Quality System Regulation violations in the firm’s manufacturing of porcelain-fused-to-metal restorations, porcelain restorations, partial dentures, and full dentures. A just-released 10/25/16 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm539979.htm?ref=fdaweb.com) says that violations included: 

- failing to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect of product quality;
- failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications;
- failing to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained;
- failing to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria;
- failing to establish and maintain procedures for implementing corrective and preventive action, including requirements for analyzing sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; and
- failing to establish and maintain procedures to control all documents.

The inspection also determined that the company failing to design, maintain, and implement written Medical Device Reporting procedures. Due to the serious nature of the violations, the letter says, FDA is detaining the company’s products without physical examination until the violations are corrected.

The firm was told to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, documentation of each action, and a timetable for completion.