Company
United StatesNikomed USA, Inc, Hatboro, PA – FDA Inspections
Inspection records and compliance data for Nikomed USA, Inc in Hatboro, Pennsylvania. 3 FDA inspections on record, 1 Form 483, last inspected February 06, 2017.
Company Profile
This profile covers Nikomed USA, Inc based in Hatboro, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected October 9, 2008. Last inspected February 6, 2017.
Most cited issue areas
- Analysis of data sources1 inspection
- Documentation1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1000189 |
| December 1, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 756748 |
| October 9, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 546209 |
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
Nikomed USA, Inc
FEI Number
2245574
Address
2800 Turnpike Dr Ste 1, Hatboro, Pennsylvania 19040, United States
Country
United States
ID: d0158e49-2a46-463e-ba47-5e6522fbb25a