FDA Inspection
Tower Medical Systems, Ltd.Tower Medical Systems, Ltd. – FDA Inspection, Feb 2, 2009
Record Details
This FDA Inspection record concerns Tower Medical Systems, Ltd., with an inspection on February 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tower Medical Systems, Ltd.
- Inspection Date
- February 2, 2009
- Product Type
- Devices
View Company Profile
ID · 45c9e959-f21c-4463-81f3-18cd92ffe65b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 564463
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)(2)Oral complaints
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
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 |
| March 30, 2011 | 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 717009 - 2011-03-30
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