# FDA 483 - Vitae Enim Vitae Scientific, Inc. - September 22, 2021

Source: https://www.globalkeysolutions.net/records/483/vitae-enim-vitae-scientific-inc/7166046c-4215-4812-9222-44d88362feea

> FDA 483 for Vitae Enim Vitae Scientific, Inc. on September 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitae Enim Vitae Scientific, Inc.
- Inspection Date: 2021-09-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Vitae Enim Vitae Scientific, Inc. in San Diego, CA, was inspected and cited for significant deficiencies across its quality control, production, facility, equipment, and laboratory operations. The inspection revealed a systemic lack of written procedures and adherence to established controls, particularly concerning change control, aseptic processing, environmental monitoring, and product release testing. These issues indicate a severe lack of control over drug product quality and sterility assurance.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.globalkeysolutions.net/companies/vitae-enim-vitae-scientific-inc/4372f617-50fd-4739-93f4-769c2bb8bdb2

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