FDA Inspection
Pentax of America IncPentax of America Inc – FDA Inspection, Sep 27, 2018
Record Details
This FDA Inspection record concerns Pentax of America Inc, with an inspection on September 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 81484047-f062-4a03-9b73-085884f39ec1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066901
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
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 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(c)Service reports/MDRs/complaints
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of Pentax of America Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pentax of America Inc
- FDA Inspection 1211451 - 2023-07-20
- FDA Inspection 921077 - 2015-04-02
- FDA Inspection 906155 - 2014-12-17
- FDA Inspection 812553 - 2012-12-18
- FDA Inspection 718354 - 2011-03-17
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