# Koros USA, Inc. – FDA Inspection, Nov 14, 2016

Source: https://www.keypedia.com/records/fda_inspections/koros-usa-inc/bc83cb4f-9a4a-4bc3-a4d7-bae14c3397de
Source feed: FDA_Inspections

> FDA inspection 991885 of Koros USA, Inc., November 14, 2016. Classification: Voluntary Action Indicated (VAI). 12 citations under 21 CFR parts 803 and 820. Form 483 issued. 4 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 991885
- Company Name: Koros USA, Inc.
- Inspection Date: 2016-11-14
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 12

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## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/koros-usa-inc/aef01499-e1c2-4032-9567-2c00bf7fbcbb

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