FDA Inspection
Southwest Technologies IncSouthwest Technologies Inc – FDA Inspection, Mar 5, 2018
Record Details
This FDA Inspection record concerns Southwest Technologies Inc, with an inspection on March 5, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e3238e5d-7de7-4e40-8e91-1ca1a82823c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043100
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Southwest Technologies Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 20, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 4, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Southwest Technologies Inc
- FDA Inspection 1238793 - 2024-05-16
- FDA Inspection 1158423 - 2021-12-08
- FDA Inspection 1083228 - 2019-03-20
- FDA Inspection 906251 - 2014-12-09
- FDA Inspection 660612 - 2010-05-04
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