FDA Inspection
Domico Med-Device LlcDomico Med-Device Llc – FDA Inspection, May 12, 2026
Record Details
This FDA Inspection record concerns Domico Med-Device Llc, with an inspection on May 12, 2026, issued by the Detroit District Office, covering medical devices & rad health.
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ID · b29118fd-b3b8-4a3a-a61c-cfd327a05806
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1316708
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.35(a)Records of complaint investigations do not include required information
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 7.6Monitoring and measurement requirements not determined
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of Domico Med-Device Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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