Company
United StatesExcelsior Medical LLC, Freehold, NJ – FDA Inspections
Inspection records and compliance data for Excelsior Medical LLC in Freehold, New Jersey. 3 FDA inspections on record, last inspected August 12, 2014.
Company Profile
This profile covers Excelsior Medical LLC based in Freehold, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 24, 2010. Last inspected August 12, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - software validation not performed1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 12, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 894469 |
| May 14, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 777713 |
| September 24, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 682455 |
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
Excelsior Medical LLC
FEI Number
3008518459
Address
317 Fairfield Rd, Freehold, New Jersey 07728, United States
Country
United States
ID: bdb16b8e-89f2-425f-8f26-358ad7f2ea85