483
Omni-Guide Holdings, Inc.FDA 483 - Omni-Guide Holdings, Inc. - August 19, 2022
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Record Details
Omni-Guide Holdings, Inc. in Billerica, MA, a medical device manufacturer, was inspected by the FDA. The inspection revealed one significant observation related to regulatory compliance. The firm failed to submit a required product report for its Beacon Advanced Energy Laser System, despite the device having received 510k approval and being distributed in commerce.
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ID · 88a305d0-2e2c-431e-a6f9-ee545d797e09