Company
United StatesAeroBiotix USA, Miamisburg, OH – FDA Inspections
Inspection records and compliance data for AeroBiotix USA in Miamisburg, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected October 01, 2026.
Company Profile
This profile covers AeroBiotix USA based in Miamisburg, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 14, 2018. Last inspected October 1, 2026.
Most cited issue areas
- Design history file1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 1, 2026 | Not classified | Medical Devices & Rad Health | 1340344 |
| April 11, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1235713 |
| March 9, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1164057 |
| November 14, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1071611 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
AeroBiotix USA
FEI Number
3014151865
Address
444 Alexandersville Rd, Miamisburg, Ohio 45342, United States
Country
United States
ID: 339f8608-64ad-4a13-9704-3a3e491373eb