FDA Inspection
Tepha IncorporatedTepha Incorporated – FDA Inspection, Feb 16, 2012
Record Details
This FDA Inspection record concerns Tepha Incorporated, with an inspection on February 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tepha Incorporated
- Inspection Date
- February 16, 2012
- Product Type
- Devices
View Company Profile
ID · cea1aa21-a06a-433a-8379-b358867c543d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 773089
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tepha Incorporated
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2008 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tepha Incorporated
- FDA Inspection 1169637 - 2022-05-13
- FDA Inspection 945984 - 2015-09-25
- FDA Inspection 557515 - 2008-10-31
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