Company
United StatesThermedx LLC - Inspection Records
Inspection records and compliance data for Thermedx LLC in Solon, Ohio. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected July 28, 2016.
Company Profile
This profile covers Thermedx LLC based in Solon, Ohio, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected December 11, 2014. Last inspected July 28, 2016.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of or inadequate process validation2 inspections
- Design Validation - Risk analysis not performed/inadequate1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Documents (5)
FDA Inspection 980937 - Thermedx LLC - 2016-07-28
fda_inspection
FDA Inspection 980937 - Thermedx LLC - 2016-07-28
fda_inspection
WARNING_LETTER - Thermedx LLC - 2014-12-11
WARNING_LETTER
FDA Inspection 906905 - Thermedx LLC - 2014-12-11
fda_inspection
FDA Inspection 906905 - Thermedx LLC - 2014-12-11
fda_inspection
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Search nearby companiesCompany Information
Name
Thermedx LLC
FEI Number
3007495879
State
Ohio
City
Solon
ID: 0190375e-19f8-4737-b8a2-ad6411f84da0