FDA Inspection
Sechrist Industries IncSechrist Industries Inc – FDA Inspection, Mar 26, 2010
Record Details
This FDA Inspection record concerns Sechrist Industries Inc, with an inspection on March 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sechrist Industries Inc
- Inspection Date
- March 26, 2010
- Product Type
- Devices
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ID · eeeaceae-0bec-456a-86cb-3b768639a87d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 654826
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.70(b)Verification or validation of changes
- 21 CFR 820.198(a)General
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.22Quality Audits - defined intervals
Showing 10 of 14 citations.
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Other FDA inspections of Sechrist Industries Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sechrist Industries Inc
- FDA Inspection 1181236 - 2022-09-14
- FDA Inspection 1035020 - 2017-12-15
- FDA Inspection 895597 - 2014-09-12
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