Company
United StatesOFS Fitel, LLC, Avon, CT – FDA Inspections
Inspection records and compliance data for OFS Fitel, LLC in Avon, Connecticut. 3 FDA inspections on record, 1 Form 483, last inspected November 07, 2024.
Company Profile
This profile covers OFS Fitel, LLC based in Avon, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 15, 2018. Last inspected November 7, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2024 | Not classified | Medical Devices & Rad Health | 1256406 |
| May 23, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1170726 |
| May 15, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1052253 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OFS Fitel, LLC
FEI Number
1221275
Address
55 Darling Dr, Avon, Connecticut 06001, United States
Country
United States
ID: d50347d5-8e15-4d3c-9d75-f251dd4c0226