FDA Inspection
Intermedic Arfran S.A.Intermedic Arfran S.A. – FDA Inspection, Feb 5, 2016
Record Details
This FDA Inspection record concerns Intermedic Arfran S.A., with an inspection on February 5, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Intermedic Arfran S.A.
- Inspection Date
- February 5, 2016
- Product Type
- Devices
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ID · d6f4093a-2562-41f9-b3db-4ab6ade2480d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958881
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
5- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 1002.13Failure to submit
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Other FDA inspections of Intermedic Arfran S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Intermedic Arfran S.A.
- FDA Inspection 1110941 - 2019-11-14
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