483
Omega Medical Imaging, Inc.Omega Medical Imaging, Inc. – FDA 483, Aug 26, 2022
Record Details
Omega Medical Imaging, Inc. in Sanford, FL, was inspected regarding its manufacturing processes for medical devices. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning inadequate procedures for corrective and preventive actions and the control of nonconforming products. These issues indicate a failure to properly address and document product discrepancies and prevent their recurrence.
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ID · 1707c91b-dd3c-4f4e-b4f6-77262d5e7f1a
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