FDA 483 - Implant Direct Sybron Manufacturing LLC - December 02, 2019

Implant Direct Sybron Manufacturing LLC in Thousand Oaks, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish and effectively implement procedures for corrective and preventive actions, leading to multiple Class II recalls for mislabeled, mispackaged, and unsterilized dental implants. Additionally, the inspection revealed inadequate procedures for medical device reporting, finished device acceptance, environmental controls in cleanrooms, and complaint handling.