# FDA 483 - B&B Medical Technologies, Inc. - February 05, 2026

Source: https://www.keypedia.com/records/483/bb-medical-technologies-inc/e7f24c54-e970-4f46-8f7f-503b94d0f52f

> FDA 483 for B&B Medical Technologies, Inc. on February 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: B&B Medical Technologies, Inc.
- Inspection Date: 2026-02-05
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of B&B Medical Technologies, Inc. in Carlsbad, CA, a medical device manufacturer, identified a significant issue with design control. The firm failed to adequately maintain design and development files for its medical devices, specifically for the Hope Nebulizer. This indicates a deficiency in ensuring conformity to design requirements and managing design changes.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/bb-medical-technologies-inc/5f9ca709-84e8-422f-b149-7198c51be9cc

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