# FDA 483 - Silk Road Medical Inc - February 27, 2020

Source: https://www.keypedia.com/records/483/silk-road-medical-inc/2dc88db3-4359-4b7a-b23d-0b7c4374f772

> FDA 483 for Silk Road Medical Inc on February 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Silk Road Medical Inc
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/silk-road-medical-inc/c2871080-3c3f-48c8-8b25-c4cfc304f47a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b