FDA Inspection
GFS Chemicals IncGFS Chemicals Inc – FDA Inspection, Mar 24, 2017
Record Details
This FDA Inspection record concerns GFS Chemicals Inc, with an inspection on March 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3c8306f-06c1-4ee0-8f3a-964bf4157ce0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006569
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GFS Chemicals Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
| 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 1223817 - 2023-11-17
- FDA Inspection 1130440 - 2020-09-04
- FDA Inspection 1087936 - 2019-04-24
- FDA Inspection 837618 - 2013-06-27
- FDA Inspection 608689 - 2009-08-20
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