483
Silk Road Medical IncSilk Road Medical Inc – FDA 483, Feb 27, 2020
Record Details
Silk Road Medical Inc, a medical device manufacturer in Sunnyvale, CA, was cited during an FDA inspection for inadequate equipment calibration procedures. The firm failed to provide a documented calibration record for a device used in product acceptance testing, indicating a lapse in quality system controls. This observation highlights a significant issue with equipment management and product quality assurance.
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ID · 2dc88db3-4359-4b7a-b23d-0b7c4374f772
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