# FDA 483 - Shape Memory Medical, Incorporation - March 13, 2025

Source: https://www.globalkeysolutions.net/records/483/shape-memory-medical-incorporation/3989f59b-5a60-450d-b002-4706e7b4dd40

> FDA 483 for Shape Memory Medical, Incorporation on March 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shape Memory Medical, Incorporation
- Inspection Date: 2025-03-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Shape Memory Medical, Incorporation in San Jose, CA, received a Form 483 for inadequate procedures related to receiving, reviewing, and evaluating complaints for its Class 2 IMPEDE FX device. The inspection found that the firm's complaint handling procedure failed to provide sufficient guidance on managing investigations, documenting investigator actions, and ensuring timely processing and escalation of complaints. Multiple complaints were closed outside of established timelines without proper documentation or escalation.

## Related Officers

- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.globalkeysolutions.net/companies/shape-memory-medical-incorporation/d82f104d-2331-4a13-b825-678944097737

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