Company
United StatesBiowave Corporation, Norwalk, CT – FDA Inspections
Inspection records and compliance data for Biowave Corporation in Norwalk, Connecticut. 6 FDA inspections on record, 3 Form 483s, last inspected May 26, 2026.
Company Profile
This profile covers Biowave Corporation based in Norwalk, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected July 28, 2010. Last inspected May 26, 2026.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 26, 2026 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1319378 |
| June 21, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1208686 |
| April 27, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009909 |
| August 28, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 846625 |
| February 18, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 711692 |
| July 28, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 675465 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biowave Corporation
FEI Number
3004558433
Address
8 Knight St, Norwalk, Connecticut 06851, United States
Country
United States
ID: ae8cd2b2-5da4-4aef-91a8-43c9dadd067a