FDA Inspection
Stradis Medical, LLC dba Stradis HealthcareStradis Medical, LLC dba Stradis Healthcare – FDA Inspection, Apr 12, 2011
Record Details
This FDA Inspection record concerns Stradis Medical, LLC dba Stradis Healthcare, with an inspection on April 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 12, 2011
- Product Type
- Devices
View Company Profile
ID · d1b4d304-7202-4c82-8e94-26a55ae5fc09
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 719657
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 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 820.198(c)Investigation of device failures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stradis Medical, LLC dba Stradis Healthcare
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 19, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 29, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 3, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Stradis Medical, LLC dba Stradis Healthcare
- FDA Inspection 1148060 - 2021-08-05
- FDA Inspection 996163 - 2016-12-19
- FDA Inspection 883715 - 2014-03-26
- FDA Inspection 770839 - 2012-02-29
- FDA Inspection 593499 - 2009-04-03
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