The FDA issued a Form 483 to Ivoclar Vivadent for noncompliant process control procedures, CAPA procedures and test/measurement equipment.
The agency issued the form after a January 2018 inspection of the company’s Amherst, NY, facility.
Investigators found the company’s soldering, press operation and foil production facilities, did not comply with procedures requiring operators to use the correct stamp for the alloy or solder being cut and stamped. The document identifying the approved stamps for each alloy and solder was retired on July 14, 2017 and an approved list was not put back in place until January 9, 2018, the agency said.
The FDA also found that several CAPAs reviewed did not include documentation for corrective actions addressing the identified root causes. Some corrective actions only documented the effectiveness check submitted to close the CAPA. Some corrective actions did not properly document review and acceptance ahead of implementation.
The investigators also observed that the company did not properly evaluate whether problems with accuracy in its test/measurement equipment had any negative impact on the quality of the devices.