FDA Inspection
Kronner Prototypes, Inc.Kronner Prototypes, Inc. – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns Kronner Prototypes, Inc., with an inspection on April 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 76869c7b-b289-431e-996f-b687fd71b29c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009807
- 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 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Kronner Prototypes, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kronner Prototypes, Inc.
- FDA Inspection 875081 - 2014-04-15
- FDA Inspection 816972 - 2013-02-04
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