Company
United StatesTransonic Systems Inc, Ithaca, NY – FDA Inspections
Inspection records and compliance data for Transonic Systems Inc in Ithaca, New York. 5 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected February 01, 2018.
Company Profile
This profile covers Transonic Systems Inc based in Ithaca, New York, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected January 26, 2010. Last inspected February 1, 2018.
Most cited issue areas
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 1, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1040245 |
| June 16, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1015982 |
| November 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 860000 |
| March 21, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 823936 |
| January 26, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 643524 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Transonic Systems Inc
FEI Number
1319030
Address
34 Dutch Mill Rd, Ithaca, New York 14850, United States
Country
United States
ID: e7fccd95-e2f9-4c0d-abbf-0afd4829e33d