FDA Inspection
Richard Wolf Medical Instruments Corp.Richard Wolf Medical Instruments Corp. – FDA Inspection, Jul 17, 2018
Record Details
This FDA Inspection record concerns Richard Wolf Medical Instruments Corp., with an inspection on July 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Emma R. Schaefer (Issuing Officer)
- Jesse A. Vazquez (FDA Associated Person)
View Company Profile
ID · a62c1c04-3a3d-4eb6-8544-ab865e3c241c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059209
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: 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 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment control activity documentation
Full citation text and observation details available on the Dashboard.
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 |
| October 10, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 8, 2013 | OAI | 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 900890 - 2014-10-10
- FDA Inspection 824521 - 2013-05-08
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