483
DS REP B.V.DS REP B.V. – FDA 483, Jun 16, 2022
Record Details
An FDA inspection of Dentsply Sirona Prosthetics in Las Piedras, PR, from June 13-16, 2022, revealed two significant issues. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including a lack of defined supplier requirements and unimplemented quality agreements. Additionally, the inspection found that personnel training, specifically for an employee conducting manufacturing operations, was not documented.
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ID · 512abc54-152e-4fd1-a5af-e6494be796cc
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