FDA Inspection
IPG PhotonicsIPG Photonics – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns IPG Photonics, with an inspection on April 13, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- James W. Whitney (Issuing Officer)
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ID · cecc646d-6573-4d00-9590-3a2d952fe5c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048545
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action - documentation
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Other FDA inspections of IPG Photonics
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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