# FDA 483 - ELITechGroup Inc. - June 27, 2025

Source: https://www.keypedia.com/records/483/elitechgroup-inc/ac23b6ee-fa0e-4e8e-8595-703c595ceb40

> FDA 483 for ELITechGroup Inc. on June 27, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ELITechGroup Inc.
- Inspection Date: 2025-06-27
- Product Type: other
- Office Name: Seattle District Office
- Summary: ELITEchGroup MDX LLC, a manufacturer in Bothell, WA, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA) and for receiving, reviewing, and evaluating complaints. These issues indicate significant deficiencies in the firm's quality system documentation and adherence to its own procedures.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/elitechgroup-inc/5dd17ee8-e1ec-4681-ad78-da7ee983eb01

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913