# Elwyn Inc – FDA Inspection, Nov 21, 2017

Source: https://www.keypedia.com/records/fda_inspections/elwyn-inc/a7fb92d1-1956-4bf7-9063-9b85fb371c1e
Source feed: FDA_Inspections

> FDA inspection 1032372 of Elwyn Inc, November 21, 2017. Classification: Voluntary Action Indicated (VAI). 3 citations under 21 CFR part 820. Form 483 issued. 3 other FDA inspections on record for this company.

---

## Details

- Record Type: FDA Inspection
- Inspection ID: 1032372
- Company Name: Elwyn Inc
- Inspection Date: 2017-11-21
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Postmarket Assurance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 3

## Related Documents

- [FDA Inspection 662987 - 2010-04-27](https://www.keypedia.com/records/fda_inspections/elwyn-inc/e1936cdf-825d-4263-a820-0c848fff4789)
- FDA Inspection 558169 - 2009-01-28
- FDA Inspection 547557 - 2008-11-12

## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.keypedia.com/companies/elwyn-inc/808c8d38-407c-4133-b08e-fce9ac715a3d

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
