FDA Inspection
Richard Wolf Medical Instruments Corp.Richard Wolf Medical Instruments Corp. – FDA Inspection, May 8, 2013
Record Details
This FDA Inspection record concerns Richard Wolf Medical Instruments Corp., with an inspection on May 8, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 8, 2013
- Product Type
- Devices
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ID · d1d43ed8-a097-4f8e-868a-ceb4212b347d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 824521
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Richard Wolf Medical Instruments Corp.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 19, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 10, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Richard Wolf Medical Instruments Corp.
- FDA Inspection 1259420 - 2025-01-13
- FDA Inspection 1203639 - 2023-04-19
- FDA Inspection 1121063 - 2020-03-18
- FDA Inspection 1059209 - 2018-07-17
- FDA Inspection 900890 - 2014-10-10
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