FDA Inspection
MEDHOST of Tennessee, Inc.MEDHOST of Tennessee, Inc. – FDA Inspection, Feb 19, 2010
Record Details
This FDA Inspection record concerns MEDHOST of Tennessee, Inc., with an inspection on February 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MEDHOST of Tennessee, Inc.
- Inspection Date
- February 19, 2010
- Product Type
- Devices
View Company Profile
ID · bee9d425-e3d4-4646-8245-b71800d0296a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648401
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MEDHOST of Tennessee, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2024 | Not classified | New Orleans District Office | |
| March 24, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 7, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for MEDHOST of Tennessee, Inc.
- FDA Inspection 1259314 - 2024-12-18
- FDA Inspection 1004832 - 2017-03-24
- FDA Inspection 920294 - 2015-03-30
- FDA Inspection 838684 - 2013-07-03
- FDA Inspection 809551 - 2012-12-07
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