FDA Inspection
GFS Chemicals IncGFS Chemicals Inc – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns GFS Chemicals Inc, with an inspection on November 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd67bcd1-30bf-46f5-a11b-915636a5f6fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223817
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of GFS Chemicals Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 24, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 20, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for GFS Chemicals Inc
- FDA Inspection 1130440 - 2020-09-04
- FDA Inspection 1087936 - 2019-04-24
- FDA Inspection 1006569 - 2017-03-24
- FDA Inspection 837618 - 2013-06-27
- FDA Inspection 608689 - 2009-08-20
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