# FDA 483 - Valencia Technologies Corporation - November 17, 2021

Source: https://www.globalkeysolutions.net/records/483/valencia-technologies-corporation/99f50a60-d120-4f48-bd6d-586193978bf9

> FDA 483 for Valencia Technologies Corporation on November 17, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valencia Technologies Corporation
- Inspection Date: 2021-11-17
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Valencia Technologies, a sponsor of investigational studies, identified one observation related to inadequate clinical monitoring. The firm failed to ensure proper monitoring for an investigational study, specifically by not conducting initial on-site monitoring visits according to its own Clinical Monitoring Plan for several study sites. This indicates a deviation from established procedures for overseeing clinical trials.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kaitlyn-t-dang/640abfda-d492-4136-b11d-59ed9016bd97)

Company: https://www.globalkeysolutions.net/companies/valencia-technologies-corporation/221c5a7a-e6b4-485e-8e20-b2b7d58a1cc9

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