# AeroBiotix USA – FDA Inspection, Nov 14, 2018

Source: https://www.keypedia.com/records/fda_inspections/aerobiotix-usa/d0b29a99-eead-40bc-94ac-4c17aa3b62cc
Source feed: FDA_Inspections

> FDA inspection 1071611 of AeroBiotix USA, November 14, 2018. Classification: Voluntary Action Indicated (VAI). 4 citations under 21 CFR parts 803 and 820. Form 483 issued. 3 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1071611
- Company Name: AeroBiotix USA
- Inspection Date: 2018-11-14
- 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: 4

## Related Documents

- FDA Inspection 1340344 - 2026-10-01
- [FDA Inspection 1235713 - 2024-04-11](https://www.keypedia.com/records/fda_inspections/aerobiotix-usa/f9146a10-18ef-4705-9884-6ab0b3e2a56b)
- FDA Inspection 1164057 - 2022-03-09

## Related Officers

- Teresa K. Kastner

Company: https://www.keypedia.com/companies/aerobiotix-usa/339f8608-64ad-4a13-9704-3a3e491373eb

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