FDA Inspection
Rocialle Healthcare Ltd. trading as GuardianRocialle Healthcare Ltd. trading as Guardian – FDA Inspection, Dec 1, 2016
Record Details
This FDA Inspection record concerns Rocialle Healthcare Ltd. trading as Guardian, with an inspection on December 1, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- December 1, 2016
- Product Type
- Medical Devices & Rad Health
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ID · 44b3d02e-d4e3-4ed1-9aa5-87aa5c7b562a
Inspection Facts
- Inspection number
- 997261
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Rocialle Healthcare Ltd. trading as Guardian
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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