FDA Inspection
Tower Medical Systems, Ltd.Tower Medical Systems, Ltd. – FDA Inspection, Mar 30, 2011
Record Details
This FDA Inspection record concerns Tower Medical Systems, Ltd., with an inspection on March 30, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tower Medical Systems, Ltd.
- Inspection Date
- March 30, 2011
- Product Type
- Devices
View Company Profile
ID · f136c1ef-1daa-48d8-9084-1ccae3da810a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 717009
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tower Medical Systems, Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 1, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 2, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tower Medical Systems, Ltd.
- FDA Inspection 1032130 - 2017-11-06
- FDA Inspection 918970 - 2015-03-11
- FDA Inspection 830728 - 2013-05-01
- FDA Inspection 564463 - 2009-02-02
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