FDA Inspection
BioMed Diagnostocs, IncBioMed Diagnostocs, Inc – FDA Inspection, Mar 13, 2026
Record Details
This FDA Inspection record concerns BioMed Diagnostocs, Inc, with an inspection on March 13, 2026, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 6a6a150a-af86-4552-ad05-3a9b35840a7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1307468
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioMed Diagnostocs, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 19, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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