# FDA 483 - Vitrolife Inc. - January 23, 2025

Source: https://www.keypedia.com/records/483/vitrolife-inc/5c2c60ef-506c-4850-ba06-09c277d5225d

> FDA 483 for Vitrolife Inc. on January 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitrolife Inc.
- Inspection Date: 2025-01-23
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Vitrolife Inc. in San Diego, CA, was inspected from January 21-23, 2025, and received one observation. The firm was cited for inadequate complaint handling, specifically regarding its procedures lacking investigation requirements for device failures and the failure to investigate a complaint about a "lint-like a hair" in a sterilized Biopsy Pipette package.

## Related Documents

- [483 - 2021-08-19](https://www.keypedia.com/records/483/vitrolife-inc/d3e7f6ed-6646-4916-941b-847a96f1e225)

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/vitrolife-inc/386a7084-7769-4be3-9a8e-9495a5ca7615

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b