Company
United StatesAktina Medical Corp, Congers, NY – FDA Inspections
Inspection records and compliance data for Aktina Medical Corp in Congers, New York. 3 FDA inspections on record, 1 Form 483, last inspected July 24, 2017.
Company Profile
This profile covers Aktina Medical Corp based in Congers, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 6, 2009. Last inspected July 24, 2017.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate process validation1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 24, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1018921 |
| February 12, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 818494 |
| November 6, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 629447 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Aktina Medical Corp
FEI Number
1000521490
Address
360 N Route 9w, Congers, New York 10920, United States
Country
United States
ID: d78d799a-6e65-4b26-825a-766d98946ebb