Company
United StatesRochester Electro Medical, Inc, Lutz, FL – FDA Inspections
Inspection records and compliance data for Rochester Electro Medical, Inc in Lutz, Florida. 3 FDA inspections on record, 1 Form 483, last inspected February 16, 2018.
Company Profile
This profile covers Rochester Electro Medical, Inc based in Lutz, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 25, 2011. Last inspected February 16, 2018.
Most cited issue areas
- Management review - Lack of or inadequate procedures1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1042005 |
| July 23, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 887868 |
| March 25, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 716839 |
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
Rochester Electro Medical, Inc
FEI Number
1000114436
Address
4212 Cypress Gulch Dr, Lutz, Florida 33559, United States
Country
United States
ID: 6b5e9d1c-8542-4eba-9d99-10305419b0a2