Company
United StatesNinepoint Medical Inc., Bedford, MA – FDA Inspections
Inspection records and compliance data for Ninepoint Medical Inc. in Bedford, Massachusetts. 1 FDA inspection on record, 1 Form 483, last inspected October 24, 2016.
Company Profile
This profile covers Ninepoint Medical Inc. based in Bedford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected October 24, 2016.
Most cited issue areas
- Design validation - production units1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 24, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 988924 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ninepoint Medical Inc.
FEI Number
3008805841
Address
12 Oak Park Dr, Bedford, Massachusetts 01730, United States
Country
United States
ID: 6c5208ac-e5af-453e-a7ea-5efbd6ebd1cb