FDA Inspection
Rad Source Technologies, Inc.Rad Source Technologies, Inc. – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Rad Source Technologies, Inc., with an inspection on March 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a5723931-6b72-4658-b141-851bf401419b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045255
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.13Failure to submit
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 806.20(b)(4)Justification for not reporting
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