Company
United StatesNeurotherm LLC, Wilmington, MA – FDA Inspections
Inspection records and compliance data for Neurotherm LLC in Wilmington, Massachusetts. 4 FDA inspections on record (1 OAI), last inspected February 04, 2016.
Company Profile
This profile covers Neurotherm LLC based in Wilmington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected December 4, 2008. Last inspected February 4, 2016.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Documentation of validated process performance1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 4, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 961078 |
| January 9, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 812556 |
| April 26, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 780115 |
| December 4, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 557710 |
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
Neurotherm LLC
FEI Number
3002953813
Address
600 Research Dr Ste 1, Wilmington, Massachusetts 01887, United States
Country
United States
ID: eb99f5c4-842d-418f-9512-cc6d3bdfd83c