FDA Inspection
BioMed Diagnostocs, IncBioMed Diagnostocs, Inc – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns BioMed Diagnostocs, Inc, with an inspection on April 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9e26a44-111d-4c02-97b2-0b43a5a719f8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1087032
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of BioMed Diagnostocs, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2026 | VAI | Los Angeles District Office | Compliance: Medical Devices |
| May 6, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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