# FDA 483 - Synexa Life Sciences - Unknown Date

Source: https://www.keypedia.com/records/483/synexa-life-sciences/098da068-63a4-4a29-b179-10a5c13d3960

> FDA 483 for Synexa Life Sciences on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synexa Life Sciences
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of Synexa Life Sciences (Pty) Ltd. in Cape Town, South Africa, revealed significant deficiencies in method validation and data integrity practices. The firm was cited for improper data exclusion, inadequate stability assessments, inconsistent application of acceptance criteria, and incomplete documentation across various assays. These issues indicate a lack of robust quality control in their contract research operations.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)

Company: https://www.keypedia.com/companies/synexa-life-sciences/54ed1a89-f031-4774-b4d2-13c5e97fc50c

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917