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•United States

PhotonX Holdings Inc., Oldsmar, FL – FDA Inspections

Inspection records and compliance data for PhotonX Holdings Inc. in Oldsmar, FL. 1 FDA inspection on record, 1 Form 483, last inspected April 04, 2017.

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Company Profile

This profile covers PhotonX Holdings Inc. based in Oldsmar, FL, United States.

FDA Inspection History

FDA inspections
1
OAI
0
VAI
0
NAI
0
Unclassified
1
Form 483s
1
Warning letters
0

Inspected April 4, 2017.

Most cited issue areas

  • Label does not contain required information1 inspection
  • Sponsor began study before IRB/FDA approval1 inspection
  • Sponsor device disposition records inadequate1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
April 4, 2017Not classifiedMedical Devices & Rad Health · Project Evaluation: Devices1014031
FDA documents

Form 483s (1)

  • Form 483s · April 4, 2017
People (1)
Courtney N. Long
Person
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Company Information

Name

PhotonX Holdings Inc.

FEI Number

3011422619

Address

640 Brooker Creek Blvd Ste 455, Oldsmar, FL 34677-2934, United States

Country

United States

ID: 6fc1d2a0-85c1-4383-b4eb-eef4f624c08b

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