# FDA 483 - LivaNova USA, Inc. - May 04, 2021

Source: https://www.keypedia.com/records/483/livanova-usa-inc/f08f6144-1e4d-4f0c-a16d-27e9cd34d840

> FDA 483 for LivaNova USA, Inc. on May 04, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LivaNova USA, Inc.
- Inspection Date: 2021-05-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of LivaNova USA, Inc. in Houston, TX, revealed a significant deficiency in process validation for its Model 105 and Model 106 Generators. The firm failed to adequately validate a critical manufacturing process, including omitting operational qualification and having insufficient acceptance criteria. This lapse in quality system procedures has resulted in ongoing field corrections for affected devices.

## Related Officers

- [Ellen J. Tave](https://www.keypedia.com/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.keypedia.com/companies/livanova-usa-inc/3eed84aa-5d07-449c-a020-ff8b2c23ca35

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab