Company
United StatesONC Solutions Incorporated, Acton, MA – FDA Inspections
Inspection records and compliance data for ONC Solutions Incorporated in Acton, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected September 10, 2019.
Company Profile
This profile covers ONC Solutions Incorporated based in Acton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 23, 2009. Last inspected September 10, 2019.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- DHR content1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1101649 |
| June 27, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 838358 |
| August 24, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678309 |
| March 23, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 571626 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ONC Solutions Incorporated
FEI Number
3006894945
Address
5 Robinwood Rd, Acton, Massachusetts 01720, United States
Country
United States
ID: 41c9522f-b3b5-4395-a7b4-f2177188ffc3