FDA Inspection
A. R. Hinkel Company, Inc. dba R.A.FischerA. R. Hinkel Company, Inc. dba R.A.Fischer – FDA Inspection, Jun 6, 2016
Record Details
This FDA Inspection record concerns A. R. Hinkel Company, Inc. dba R.A.Fischer, with an inspection on June 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 6, 2016
- Product Type
- Devices
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ID · f15c90a7-6f66-4f06-8cb6-caf0499cf59c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971941
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of A. R. Hinkel Company, Inc. dba R.A.Fischer
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 24, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 18, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for A. R. Hinkel Company, Inc. dba R.A.Fischer
- FDA Inspection 1197738 - 2023-01-13
- FDA Inspection 1115813 - 2020-01-24
- FDA Inspection 806461 - 2012-10-18
- FDA Inspection 695293 - 2010-10-27
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