Company
United StatesSoterix Medical, Inc., New York, NY – FDA Inspections
Inspection records and compliance data for Soterix Medical, Inc. in New York, New York. 2 FDA inspections on record, 2 Form 483s, last inspected September 19, 2018.
Company Profile
This profile covers Soterix Medical, Inc. based in New York, New York, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected August 24, 2017. Last inspected September 19, 2018.
Most cited issue areas
- DMR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2018 | Not classified | Medical Devices & Rad Health | 1122115 |
| August 24, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1023290 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Soterix Medical, Inc.
FEI Number
3012182497
Address
237 W 35th St Ste 1401, New York, New York 10001, United States
Country
United States
ID: a7eb1261-0277-49dc-8b26-c446fc69aac6