# BioMed Diagnostocs, Inc – FDA 483, Mar 13, 2026

Source: https://www.keypedia.com/records/483/biomed-diagnostocs-inc/bea47b17-d144-47f6-8343-baaaec08ae88

> FDA 483 for BioMed Diagnostocs, Inc on March 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMed Diagnostocs, Inc
- Inspection Date: 2026-03-13
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: During an inspection, Diagnostic Consulting Network, LLC, a manufacturer of Research Use Only (RUO) products in Carlsbad, CA, was cited for significant deficiencies in its quality system. Observations included inadequate document control procedures, leading to obsolete RUO product information with clinical claims remaining on its website, and a lack of systematic review for marketing materials. Additionally, the firm failed to adequately maintain records of risk management activities, specifically regarding contradictory marketing claims for RUO products and the absence of risk assessments for their potential clinical misuse.

## Related Documents

- [483 - 2022-05-06](https://www.keypedia.com/records/483/biomed-diagnostocs-inc/b22e4d00-aca2-4f20-9f70-8ba303b7e043) — date: May 6, 2022

## Related Officers

- [Jenny L. Chisem](https://www.keypedia.com/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.keypedia.com/companies/biomed-diagnostocs-inc/ca887e90-9e4c-410e-a02b-e48111041515

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b