FDA 483 - Green Dental Lab - June 13, 2023
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Green Dental Lab, a contract manufacturer in Heber Springs, AR, was cited for two observations during an FDA inspection. The firm failed to adequately review and evaluate customer complaints to determine if an investigation was necessary, and did not maintain proper records for decisions not to investigate. Additionally, procedures for controlling nonconforming products were not adequately established, as Product Nonconforming Reports were not generated for identified nonconformances related to their Class II EMA anti-snoring device.
ID · 4b028d72-f31a-4a3d-9090-db234108d9d1