FDA Inspection
Pentax of America IncPentax of America Inc – FDA Inspection, Mar 17, 2011
Record Details
This FDA Inspection record concerns Pentax of America Inc, with an inspection on March 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pentax of America Inc
- Inspection Date
- March 17, 2011
- Product Type
- Devices
View Company Profile
ID · 393821c2-8999-4d3c-a5c4-d57d9a9c5ea1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718354
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
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 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2012 | OAI | 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 906155 - 2014-12-17
- FDA Inspection 812553 - 2012-12-18
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