FDA Inspection
Stradis Medical, LLC dba Stradis HealthcareStradis Medical, LLC dba Stradis Healthcare – FDA Inspection, Apr 3, 2009
Record Details
This FDA Inspection record concerns Stradis Medical, LLC dba Stradis Healthcare, with an inspection on April 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 3, 2009
- Product Type
- Devices
View Company Profile
ID · c830fbf0-06a2-4384-b1a8-ed556197bb60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 593499
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product evaluation/investigation
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 12, 2011 | OAI | Center for Devices and Radiological Health | Compliance: 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 719657 - 2011-04-12
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