FDA Inspection
Paragon DX, LLCParagon DX, LLC – FDA Inspection, Aug 18, 2009
Record Details
This FDA Inspection record concerns Paragon DX, LLC, with an inspection on August 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Paragon DX, LLC
- Inspection Date
- August 18, 2009
- Product Type
- Devices
View Company Profile
ID · 667fd5c0-a2c3-46db-b10e-518b1c7102f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605490
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(e)Design reviews performed following schedule
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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