Company
United StatesDiamedix Corporation, Miami Lakes, FL – FDA Inspections
Inspection records and compliance data for Diamedix Corporation in Miami Lakes, Florida. 2 FDA inspections on record, last inspected March 17, 2016.
Company Profile
This profile covers Diamedix Corporation based in Miami Lakes, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 18, 2009. Last inspected March 17, 2016.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 969986 |
| August 18, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 605567 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Diamedix Corporation
FEI Number
1044713
Address
14100 Nw 57th Ct, Miami Lakes, Florida 33014, United States
Country
United States
ID: f5b0ed73-8199-4a18-9d68-8785554abb8b