FDA Inspection
Kapp Surgical Instrument IncKapp Surgical Instrument Inc – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Kapp Surgical Instrument Inc, with an inspection on November 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7ca96367-d2c0-4f1f-9863-9f891abe7a19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071836
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Kapp Surgical Instrument Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Kapp Surgical Instrument Inc
- FDA Inspection 915420 - 2015-02-24
- FDA Inspection 716182 - 2011-03-22
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