FDA Inspection
Inditherm MedicalInditherm Medical – FDA Inspection, Oct 30, 2008
Record Details
This FDA Inspection record concerns Inditherm Medical, with an inspection on October 30, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Inditherm Medical
- Inspection Date
- October 30, 2008
- Product Type
- Devices
View Company Profile
ID · b8162ad2-3a67-422c-a700-4e265cc0b61a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 549629
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.184DHR content
- 21 CFR 803.17(b)(2)Reports and information documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Inditherm Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Inditherm Medical
- FDA Inspection 665536 - 2010-04-29
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.