FDA Inspection
Schiller MedicalSchiller Medical – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Schiller Medical, with an inspection on March 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 444a5a3c-a521-4245-a0c5-c873f8b4943a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045200
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
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