# FDA 483 - Helena C. Chang, MD - February 20, 2026

Source: https://www.keypedia.com/records/483/helena-c-chang-md/81e5429a-fbd4-4540-83bf-a3718cc08788

> FDA 483 for Helena C. Chang, MD on February 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Helena C. Chang, MD
- Inspection Date: 2026-02-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Helena C. Chang, MD in Santa Clara, CA, a clinical investigator, was inspected by the FDA. The inspection revealed that the firm failed to maintain complete and accurate accountability records for investigational devices. Specifically, Break Wave Therapy Probes used in a pivotal clinical trial lacked proper disposition records.

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/stephanie-barragan/fc1bc901-1467-4fdd-bee3-f87f2db3a1fa)

Company: https://www.keypedia.com/companies/helena-c-chang-md/022d1cd6-d8f0-4ca3-810c-6e4e09fd628f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b