Company
United StatesDiomedics, Inc., Waldo, FL – FDA Inspections
Inspection records and compliance data for Diomedics, Inc. in Waldo, Florida. 3 FDA inspections on record, 1 Form 483, last inspected May 19, 2017.
Company Profile
This profile covers Diomedics, Inc. based in Waldo, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 15, 2009. Last inspected May 19, 2017.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1017180 |
| November 6, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 806234 |
| April 15, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 575786 |
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
Diomedics, Inc.
FEI Number
1000222160
Address
18012 Ne 136th Ave, Waldo, Florida 32694, United States
Country
United States
ID: 4db3bfb8-f68e-4088-a80e-c086e2016745