Company
United StatesCirculatory Technology Inc., Oyster Bay, NY – FDA Inspections
Inspection records and compliance data for Circulatory Technology Inc. in Oyster Bay, New York. 7 FDA inspections on record (2 OAI), 1 Form 483, last inspected December 04, 2019.
Company Profile
This profile covers Circulatory Technology Inc. based in Oyster Bay, New York, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 15, 2010. Last inspected December 4, 2019.
Most cited issue areas
- Documentation4 inspections
- Design history file3 inspections
- Design validation acceptance criteria3 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 4, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1111775 |
| September 26, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1067277 |
| July 8, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 976745 |
| July 31, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 936945 |
| March 11, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 822890 |
| April 25, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 723898 |
| March 15, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 652147 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Circulatory Technology Inc.
FEI Number
1000522036
Address
21 Singworth St, Oyster Bay, New York 11771, United States
Country
United States
ID: 255fb45c-cf2e-4267-9a72-23bb35fe3e5e