FDA Inspection
Merete GmbHMerete GmbH – FDA Inspection, Aug 29, 2018
Record Details
This FDA Inspection record concerns Merete GmbH, with an inspection on August 29, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · bdd0e2f1-3196-4c1d-9153-1daee49ac242
Inspection Facts
- Inspection number
- 1064237
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Merete GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 5, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Merete GmbH
- FDA Inspection 1170976 - 2022-05-05
- FDA Inspection 600292 - 2009-07-02
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