FDA Inspection
Pentax of America IncPentax of America Inc – FDA Inspection, Dec 17, 2014
Record Details
This FDA Inspection record concerns Pentax of America Inc, with an inspection on December 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pentax of America Inc
- Inspection Date
- December 17, 2014
- Product Type
- Devices
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ID · 853f56eb-10ea-4b19-bd7e-f630de314843
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906155
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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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 |
| September 27, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 2, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1066901 - 2018-09-27
- FDA Inspection 921077 - 2015-04-02
- FDA Inspection 812553 - 2012-12-18
- FDA Inspection 718354 - 2011-03-17
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