Company
United StatesTower Medical Systems, Ltd., Holbrook, NY – FDA Inspections
Inspection records and compliance data for Tower Medical Systems, Ltd. in Holbrook, New York. 5 FDA inspections on record, last inspected November 06, 2017.
Company Profile
This profile covers Tower Medical Systems, Ltd. based in Holbrook, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected February 2, 2009. Last inspected November 6, 2017.
Most cited issue areas
- Design control - no procedures1 inspection
- DHR content1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 6, 2017 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1032130 |
| March 11, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 918970 |
| May 1, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 830728 |
| March 30, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 717009 |
| February 2, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 564463 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Tower Medical Systems, Ltd.
FEI Number
3003747574
Address
917 Lincoln Ave Ste 11, Holbrook, New York 11741, United States
Country
United States
ID: 0f4241d8-c6b0-4fad-a4e9-df9bcf919eff