Medical Design Instruments Gets 483 on Supplier Controls
Medical Design Instruments has received an FDA Form 483 for poor supplier controls.
The company did not have a written agreement that suppliers, contractors or consultants must notify it of changes made to its Spinouspreader device. The devices facilitate mini-midline lumbar decompressions, according to the company’s website.
Meanwhile, the device history record for the Spinouspreader did not include the complete primary identification labeling and packaging, the April 25 form says. It was recently released by the FDA.
Medical Design Instruments did not respond to a request for comment by press time.
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