# FDA 483 - Vitrolife, Inc. - February 13, 2019

Source: https://www.globalkeysolutions.net/records/483/vitrolife-inc/486d7fba-1308-4099-81fc-0e6f9788bdaa

> FDA 483 for Vitrolife, Inc. on February 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitrolife, Inc.
- Inspection Date: 2019-02-13
- Product Type: device
- Office Name: Denver District Office
- Summary: During an inspection, Vitrolife, Inc., a medical device manufacturer in Englewood, CO, was cited for two significant issues. The firm failed to make required quality system records readily available for FDA review due to a viral infection affecting their automated systems. Additionally, the inspection revealed that process validation for sterilization equipment was not adequately documented or approved, with validation activities occurring before plan approval.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/vitrolife-inc/c68ca9d8-493a-425f-a9fc-5521dbbc05dc

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face