Company
United StatesO2 Concepts, LLC, Middlebury, CT – FDA Inspections
Inspection records and compliance data for O2 Concepts, LLC in Middlebury, Connecticut. 2 FDA inspections on record, 1 Form 483, last inspected January 11, 2024.
Company Profile
This profile covers O2 Concepts, LLC based in Middlebury, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 10, 2018. Last inspected January 11, 2024.
Most cited issue areas
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1227231 |
| January 10, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1037620 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
O2 Concepts, LLC
FEI Number
3008910673
Address
199 Park Road Ext Ste B, Middlebury, Connecticut 06762, United States
Country
United States
ID: 0b3246a0-1382-4c71-880e-d4109cff75a6