# FDA 483 - BioMed Diagnostocs, Inc - May 06, 2022

Source: https://www.globalkeysolutions.net/records/483/biomed-diagnostocs-inc/b22e4d00-aca2-4f20-9f70-8ba303b7e043

> FDA 483 for BioMed Diagnostocs, Inc on May 06, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMed Diagnostocs, Inc
- Inspection Date: 2022-05-06
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: BioMed Holdings LLC, a manufacturer in White City, OR, was cited for nine observations during an FDA inspection from May 2-6, 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for CAPA, complaint handling, equipment calibration and maintenance, environmental control, nonconforming product, supplier management, training, and internal audits. These issues indicate a systemic lack of adherence to established quality management principles.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822