Company
United StatesNonin Medical, Inc, Plymouth, MN – FDA Inspections
Inspection records and compliance data for Nonin Medical, Inc in Plymouth, Minnesota. 4 FDA inspections on record, last inspected July 18, 2024.
Company Profile
This profile covers Nonin Medical, Inc based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected September 24, 2010. Last inspected July 18, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - software validation not performed1 inspection
- Not approved or obsolete document retrieval1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 18, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1245893 |
| February 29, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 967579 |
| November 15, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 807070 |
| September 24, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 683432 |
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
Nonin Medical, Inc
FEI Number
2183646
Address
13700 1st Ave N, Plymouth, Minnesota 55441, United States
Country
United States
ID: 4beab4c8-21c4-4e7a-aad2-e6f909aa2247