FDA Inspection
GFS Chemicals IncGFS Chemicals Inc – FDA Inspection, Apr 24, 2019
Record Details
This FDA Inspection record concerns GFS Chemicals Inc, with an inspection on April 24, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 55bf24c0-2fb2-45ad-b67d-ff42d4126257
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1087936
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
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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 |
| 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 1223817 - 2023-11-17
- FDA Inspection 1130440 - 2020-09-04
- FDA Inspection 1006569 - 2017-03-24
- FDA Inspection 837618 - 2013-06-27
- FDA Inspection 608689 - 2009-08-20
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