FDA Inspection
AMF, SarlAMF, Sarl – FDA Inspection, Mar 29, 2017
Record Details
This FDA Inspection record concerns AMF, Sarl, with an inspection on March 29, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e15c50bc-79be-420f-8faf-cc8b37a28ec7
Inspection Facts
- Inspection number
- 1008195
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of AMF, Sarl
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AMF, Sarl
- FDA Inspection 814591 - 2012-12-06
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