Company
United KingdomInditherm Medical, Rotherham, United Kingdom – FDA Inspections
Inspection records and compliance data for Inditherm Medical in Rotherham. 2 FDA inspections on record (1 OAI), last inspected April 29, 2010.
Company Profile
This profile covers Inditherm Medical based in Rotherham, United Kingdom.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 30, 2008. Last inspected April 29, 2010.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR content1 inspection
- Justification for not reporting1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 29, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 665536 |
| October 30, 2008 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 549629 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Inditherm Medical
FEI Number
3005246910
Address
Houndhill Park, Bolton Road, Rotherham, United Kingdom
Country
United Kingdom
ID: 40b5ff40-d13a-4d48-a446-cd07287d3261