FDA Inspection
Stradis Medical, LLC dba Stradis HealthcareStradis Medical, LLC dba Stradis Healthcare – FDA Inspection, Mar 26, 2014
Record Details
This FDA Inspection record concerns Stradis Medical, LLC dba Stradis Healthcare, with an inspection on March 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 26, 2014
- Product Type
- Devices
View Company Profile
ID · 24650a95-d0f1-4582-9220-1c098acece10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 883715
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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 |
| February 29, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 12, 2011 | OAI | Center for Devices and Radiological Health | Compliance: 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 770839 - 2012-02-29
- FDA Inspection 719657 - 2011-04-12
- FDA Inspection 593499 - 2009-04-03
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