FDA Inspection
Southwest Technologies IncSouthwest Technologies Inc – FDA Inspection, Mar 20, 2019
Record Details
This FDA Inspection record concerns Southwest Technologies Inc, with an inspection on March 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8850239-b0a7-47a1-a194-5fc3bda8c295
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083228
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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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 5, 2018 | VAI | Center for Devices and Radiological Health | Compliance: 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 1043100 - 2018-03-05
- FDA Inspection 906251 - 2014-12-09
- FDA Inspection 660612 - 2010-05-04
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