Company
United StatesExcelsior Medical LLC, Neptune, NJ – FDA Inspections
Inspection records and compliance data for Excelsior Medical LLC in Neptune, New Jersey. 5 FDA inspections on record (2 OAI), last inspected July 20, 2016.
Company Profile
This profile covers Excelsior Medical LLC based in Neptune, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 8, 2010. Last inspected July 20, 2016.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design validation - user needs and intended uses1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 985550 |
| September 29, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 944051 |
| August 21, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 893818 |
| May 14, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 777712 |
| January 8, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 637937 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Excelsior Medical LLC
FEI Number
1000122362
Address
1933 Heck Ave, Neptune, New Jersey 07753, United States
Country
United States
ID: 5f05cf2d-22e7-40ea-9aa1-68583e79b575