Company
United StatesOn Site Gas Systems Inc., Newington, CT – FDA Inspections
Inspection records and compliance data for On Site Gas Systems Inc. in Newington, Connecticut. 5 FDA inspections on record, 2 Form 483s, last inspected May 15, 2024.
Company Profile
This profile covers On Site Gas Systems Inc. based in Newington, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 17, 2011. Last inspected May 15, 2024.
Most cited issue areas
- DMR - not or inadequately maintained2 inspections
- Design history file1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1239657 |
| March 14, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1083336 |
| October 3, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1027504 |
| December 19, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 860091 |
| February 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 712640 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
On Site Gas Systems Inc.
FEI Number
3003637574
Address
35 Budney Rd, Newington, Connecticut 06111, United States
Country
United States
ID: 2506357f-69e2-48ba-842e-8f4a526b1eae