FDA Inspection
APPLIMED SA-CSSRAPPLIMED SA-CSSR – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns APPLIMED SA-CSSR, with an inspection on May 17, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 7ceae647-f2b1-41c0-b2b7-0660b292c47b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055590
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.65Traceability Lack of or inadequate {see also 820.120(e)}
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