FDA Inspection
Nuclea Diagnostic Laboratories, LLC.Nuclea Diagnostic Laboratories, LLC. – FDA Inspection, Dec 6, 2013
Record Details
This FDA Inspection record concerns Nuclea Diagnostic Laboratories, LLC., with an inspection on December 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 6, 2013
- Product Type
- Devices
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ID · 204525fc-f0c0-4f11-b8f8-adabab634883
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858624
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Nuclea Diagnostic Laboratories, LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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