FDA Inspection
Wall Medical, Inc.Wall Medical, Inc. – FDA Inspection, Aug 21, 2026
Record Details
This FDA Inspection record concerns Wall Medical, Inc., with an inspection on August 21, 2026, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · d5bc3a75-aafc-47d9-9d5b-6c2f0f2a7fbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1332408
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 4.2.4Lack of document control
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
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Other FDA inspections of Wall Medical, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 29, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wall Medical, Inc.
- FDA Inspection 1047807 - 2018-01-25
- FDA Inspection 904367 - 2014-10-30
- FDA Inspection 902437 - 2014-10-29
- FDA Inspection 765672 - 2012-01-26
- FDA Inspection 732129 - 2011-06-29
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