FDA Inspection
Maico Diagnostic GmbHMaico Diagnostic GmbH – FDA Inspection, Oct 12, 2017
Record Details
This FDA Inspection record concerns Maico Diagnostic GmbH, with an inspection on October 12, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d5281d7a-da9b-40d7-8b83-269b22bacf7e
Inspection Facts
- Inspection number
- 1028434
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
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