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Medical Devices / Inspections and Audits

Documentation, Contamination Issues Draw 483 for Chinese Implant Company

Oct. 12, 2016
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A June inspection found Guangdong, China-based Implant Dental Technology deficient in numerous good manufacturing practices, according to a seven-item Form 483.

The dental implant manufacturer failed to implement procedures to prevent contamination of equipment or product.

The inspector noted that there was unidentified brown particle accumulation in four different locations in the plant, and the firm was using tap water rather than sterile or purified water. — Tamra Sami

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