FDA Inspection
Richard Wolf Medical Instruments Corp.Richard Wolf Medical Instruments Corp. – FDA Inspection, Oct 9, 2009
Record Details
This FDA Inspection record concerns Richard Wolf Medical Instruments Corp., with an inspection on October 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 9, 2009
- Product Type
- Devices
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ID · 2c62923b-7b2b-45ff-9aa5-4dfb6cc9c30b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 619929
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.72(b)(2)Calibration documentation
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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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