Implant Dental Tech. Warned About Contamination
The FDA hit Guangdong, China-based Implant Dental Technology with a warning letter citing equipment contamination, production deficiencies, and other violations.
After inspecting the company’s facility in June 2106, the FDA said the company failed to prevent contamination of equipment. For example, four steam cleaners — located in clean rooms and used to clean dental implants — had unidentified green or brown particulate accumulation in the water tanks.
The company also failed to develop production processes to ensure that devices conformed to their specifications. For example, Implant Dental’s procedures lacked instructions for using furnaces to heat metals and process porcelains for dental implants. In addition, the firm did not document times and temperatures for the processes.
The warning letter further cited Implant Dental for failing to establish and maintain procedures to ensure that equipment was routinely calibrated, inspected, checked, and maintained. For example, there was no evidence that equipment used to measure the wall thickness of ceramic teeth was calibrated.
The company also failed to ensure that incoming products were properly marked for temporary storage or use during manufacturing.
In addition, the warning letter said the company failed to implement corrective and preventive actions and requirements for analyzing quality data to identify causes of nonconforming products.
Lastly, the FDA faulted the company’s document control procedures, citing a failure to maintain records of changes to documents and other deficiencies.
Implant Dental did not return a request for comment.
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out.