FDA Inspection
Materna MedicalMaterna Medical – FDA Inspection, Aug 26, 2026
Record Details
This FDA Inspection record concerns Materna Medical, with an inspection on August 26, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Materna Medical
- Inspection Date
- August 26, 2026
- Product Type
- Devices
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ID · 2740dbe5-b4b4-4703-b85b-61c0bb0d9861
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1333460
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 8.5.2Corrective actions not proportionate to the effects of nonconformities
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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