Company
United StatesCogentix Medical, Inc., Orangeburg, NY – FDA Inspections
Inspection records and compliance data for Cogentix Medical, Inc. in Orangeburg, New York. 4 FDA inspections on record, last inspected April 14, 2022.
Company Profile
This profile covers Cogentix Medical, Inc. based in Orangeburg, New York, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 11, 2011. Last inspected April 14, 2022.
Most cited issue areas
- Documentation2 inspections
- Acceptable supplier records, inadequate records1 inspection
- Design review - documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 14, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1167401 |
| August 8, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 890802 |
| May 1, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831310 |
| February 11, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 711939 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cogentix Medical, Inc.
FEI Number
2242464
Address
40 Ramland Rd Ste 1, Orangeburg, New York 10962, United States
Country
United States
ID: f390823b-956f-4ec5-adcc-32c9dc279ec6