Company
United StatesFen Dental Mfg, Inc., Medley, FL – FDA Inspections
Inspection records and compliance data for Fen Dental Mfg, Inc. in Medley, Florida. 4 FDA inspections on record, 1 Form 483, last inspected December 01, 2017.
Company Profile
This profile covers Fen Dental Mfg, Inc. based in Medley, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 24, 2009. Last inspected December 1, 2017.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures - Acceptance activities2 inspections
- Lack of Written MDR Procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1032513 |
| December 11, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 906897 |
| July 28, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 674667 |
| April 24, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 578075 |
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
Fen Dental Mfg, Inc.
FEI Number
1000221959
Address
11405 Nw 122nd St, Medley, Florida 33178, United States
Country
United States
ID: 28ff089c-957f-45c7-bbd0-c9c9c6746f97