FDA Inspection
Spatz FGIA, IncSpatz FGIA, Inc – FDA Inspection, Aug 9, 2019
Record Details
This FDA Inspection record concerns Spatz FGIA, Inc, with an inspection on August 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b9213149-9d74-4dcf-92e4-fe39c56e5353
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099803
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Spatz FGIA, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spatz FGIA, Inc
- FDA Inspection 1194697 - 2022-12-15
- FDA Inspection 1107557 - 2019-09-25
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