FDA Inspection
Robin Industries Healthcare DivisionRobin Industries Healthcare Division – FDA Inspection, Sep 26, 2023
Record Details
This FDA Inspection record concerns Robin Industries Healthcare Division, with an inspection on September 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0d2f6620-6b2b-43f9-91f4-acd92f458ce9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219662
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.72(a)Equipment control activity documentation
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Other FDA inspections of Robin Industries Healthcare Division
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Robin Industries Healthcare Division
- FDA Inspection 1151713 - 2021-08-30
- FDA Inspection 984251 - 2016-08-25
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