483
B&B Medical Technologies, Inc.B&B Medical Technologies, Inc. – FDA 483, Feb 5, 2026
Record Details
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.
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ID · e7f24c54-e970-4f46-8f7f-503b94d0f52f
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