FDA Inspection
Nonin Medical, IncNonin Medical, Inc – FDA Inspection, Sep 24, 2010
Record Details
This FDA Inspection record concerns Nonin Medical, Inc, with an inspection on September 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nonin Medical, Inc
- Inspection Date
- September 24, 2010
- Product Type
- Devices
View Company Profile
ID · 11e4bab5-401c-4940-b2b7-deeafdd19a3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 683432
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nonin Medical, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 29, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nonin Medical, Inc
- FDA Inspection 1245893 - 2024-07-18
- FDA Inspection 967579 - 2016-02-29
- FDA Inspection 807070 - 2012-11-15
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