# FDA 483 - Vitrolife Inc. - August 19, 2021

Source: https://www.globalkeysolutions.net/records/483/vitrolife-inc/d3e7f6ed-6646-4916-941b-847a96f1e225

> FDA 483 for Vitrolife Inc. on August 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitrolife Inc.
- Inspection Date: 2021-08-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Vitrolife Inc. in San Diego, CA, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in equipment maintenance schedules, documentation of acceptance activities for device history records, establishment of corrective and preventive action procedures, and the lack of statistically valid sampling plans. These issues indicate a need for comprehensive improvements in the firm's quality system for manufacturing medical devices.

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## Related Officers

- [Angelica G Aziz](https://www.globalkeysolutions.net/people/angelica-g-aziz/3aea89c9-72d6-4865-984e-936dd61d2786)

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

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6