Company
United StatesCase Medical, Inc., Bloomfield, NJ – FDA Inspections
Inspection records and compliance data for Case Medical, Inc. in Bloomfield, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected October 12, 2023.
Company Profile
This profile covers Case Medical, Inc. based in Bloomfield, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 24, 2009. Last inspected October 12, 2023.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Complaints1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 12, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1220232 |
| November 29, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1037164 |
| January 23, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 765382 |
| March 24, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 572705 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Case Medical, Inc.
FEI Number
1000526834
Address
50 West St, Bloomfield, New Jersey 07003, United States
Country
United States
ID: 031b077c-18aa-444a-b4da-7ca746875c8d