FDA Inspection
Osada IncOsada Inc – FDA Inspection, Sep 17, 2019
Record Details
This FDA Inspection record concerns Osada Inc, with an inspection on September 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5ba1bc2-f808-4755-9b0b-8b4b34d1d328
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102145
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.120Lack of or inadequate procedures for labeling
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Osada Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 20, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Osada Inc
- FDA Inspection 1063754 - 2018-02-27
- FDA Inspection 866669 - 2014-02-20
- FDA Inspection 729463 - 2011-06-14
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