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Home » FDA Raps Orthopedic Devicemaker for Process Controls

FDA Raps Orthopedic Devicemaker for Process Controls

October 12, 2020
Medical Devices Inspections and Audits
The FDA found orthopedic devicemaker BioSculptor’s production processes were “not developed, controlled and monitored to ensure that a device conforms to its specifications,” according to a 483 the firm received following an FDA inspection at its Hialeah, Florida facility.

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