FDA Inspection
Norfolk Medical Products, Inc.Norfolk Medical Products, Inc. – FDA Inspection, Nov 2, 2018
Record Details
This FDA Inspection record concerns Norfolk Medical Products, Inc., with an inspection on November 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f70938c8-f091-4016-ba24-5eec3f51d1e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071013
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Norfolk Medical Products, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 26, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Norfolk Medical Products, Inc.
- FDA Inspection 1257901 - 2024-12-18
- FDA Inspection 1175430 - 2022-07-26
- FDA Inspection 914263 - 2015-02-11
- FDA Inspection 644310 - 2010-02-04
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