FDA Inspection
G-5 Florida LLCG-5 Florida LLC – FDA Inspection, Jul 17, 2019
Record Details
This FDA Inspection record concerns G-5 Florida LLC, with an inspection on July 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89c3b6e1-ac93-4222-8e0e-c273441e96bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097607
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of G-5 Florida LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 22, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for G-5 Florida LLC
- FDA Inspection 941651 - 2015-09-10
- FDA Inspection 805499 - 2012-10-22
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