# Gauthier Biomedical, Inc. – FDA Inspection, Dec 15, 2016

Source: https://www.keypedia.com/records/fda_inspections/gauthier-biomedical-inc/ff0d4962-bdbc-473a-ade3-64e8b5824483
Source feed: FDA_Inspections

> FDA inspection 998349 of Gauthier Biomedical, Inc., December 15, 2016. Classification: Voluntary Action Indicated (VAI). 6 citations under 21 CFR parts 803 and 820. Form 483 issued. 2 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 998349
- Company Name: Gauthier Biomedical, Inc.
- Inspection Date: 2016-12-15
- 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: 6

## Related Documents

- FDA Inspection 1258347 - 2025-01-08
- [FDA Inspection 1159937 - 2021-12-21](https://www.keypedia.com/records/fda_inspections/gauthier-biomedical-inc/c48a50d2-fcec-4a4f-a0ec-eb4a90602ad5)

## Related Officers

- [Company Rep](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.keypedia.com/companies/gauthier-biomedical-inc/bf287207-fc1f-4b2e-963d-3f0c33b1bcec

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