FDA Inspection
STRATEC SESTRATEC SE – FDA Inspection, Apr 18, 2019
Record Details
This FDA Inspection record concerns STRATEC SE, with an inspection on April 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b533ab05-e69b-4058-94c3-5a393bdeffec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087247
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of STRATEC SE
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for STRATEC SE
- FDA Inspection 840250 - 2013-06-06
- FDA Inspection 712776 - 2011-02-10
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