FDA Inspection
STRATEC SESTRATEC SE – FDA Inspection, Jun 6, 2013
Record Details
This FDA Inspection record concerns STRATEC SE, with an inspection on June 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- STRATEC SE
- Inspection Date
- June 6, 2013
- Product Type
- Devices
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ID · 2f272b05-f8f0-4f3c-b05f-4080835a65bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840250
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
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Other FDA inspections of STRATEC SE
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2019 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| February 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for STRATEC SE
- FDA Inspection 1087247 - 2019-04-18
- FDA Inspection 712776 - 2011-02-10
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