FDA Inspection
NOVAF ANDALUCIA 2007, S.L.NOVAF ANDALUCIA 2007, S.L. – FDA Inspection, Mar 12, 2024
Record Details
This FDA Inspection record concerns NOVAF ANDALUCIA 2007, S.L., with an inspection on March 12, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b322175a-fefa-47a6-a974-0a936ee4fdbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1234073
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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