Company
United StatesImmunostics, Inc., Eatontown, NJ – FDA Inspections
Inspection records and compliance data for Immunostics, Inc. in Eatontown, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected November 08, 2017.
Company Profile
This profile covers Immunostics, Inc. based in Eatontown, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected July 13, 2010. Last inspected November 8, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 8, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1031471 |
| December 3, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 808912 |
| February 18, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 709502 |
| July 13, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 671330 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Immunostics, Inc.
FEI Number
2244821
Address
38 Industrial Way E Ste 1, Eatontown, New Jersey 07724, United States
Country
United States
ID: 5f1f97d2-a8fc-4482-af95-027053419c2f