FDA Inspection
Prexion, Inc.Prexion, Inc. – FDA Inspection, Aug 22, 2018
Record Details
This FDA Inspection record concerns Prexion, Inc., with an inspection on August 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · 617880a0-0871-438f-a781-1455887cf22d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064537
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of Prexion, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 26, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Prexion, Inc.
- FDA Inspection 858562 - 2013-12-26
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