# FDA 483 - Q'apel Medical, Inc. - March 08, 2022

Source: https://www.keypedia.com/records/483/qapel-medical-inc/eb6d8ea2-de87-4c3d-a6fe-6fc71cf3e571

> FDA 483 for Q'apel Medical, Inc. on March 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Q'apel Medical, Inc.
- Inspection Date: 2022-03-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Q'apel Medical, Inc. in Fremont, CA, a manufacturer of medical devices, was cited for significant deficiencies in its quality system. The firm failed to submit Medical Device Reports (MDRs) for serious malfunctions of its Walrus Balloon Guide Catheter System and did not adequately implement its Corrective and Preventive Action (CAPA) procedure for complaint trending. These issues indicate a failure to properly address and report device-related adverse events.

## Related Documents

- [WARNING_LETTER - 2024-08-08](https://www.keypedia.com/records/warning_letter/qapel-medical-inc/5ad007a8-5c97-4c72-8e1b-6fd29d3d9b65)

## Related Officers

- [investigator](https://www.keypedia.com/people/maida-henesian/cd28e878-000c-4af8-8dbd-4863057758bb)

Company: https://www.keypedia.com/companies/qapel-medical-inc/fb20bd08-a920-42f6-bbf8-804a409de17e

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