FDA Inspection
PhotonX Holdings Inc.PhotonX Holdings Inc. – FDA Inspection, Apr 4, 2017
Record Details
This FDA Inspection record concerns PhotonX Holdings Inc., with an inspection on April 4, 2017, issued by the Florida District Office, covering medical devices & rad health.
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ID · 73c5451f-21cc-4cd9-ae53-22f210cb33d4
Inspection Facts
- Inspection number
- 1014031
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(5)Sponsor records of adverse device effects & complaints
- 21 CFR 812.40Sponsors' general responsibilities
- 21 CFR 812.42Sponsor began study before IRB/FDA approval
- 21 CFR 812.43(b)Sponsor shipped devices to unqualified person(s)
- 21 CFR 812.5(a)Label does not contain required information
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