483
Synexa Life SciencesFDA 483 - Synexa Life Sciences
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Record Details
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.
- Company
- Synexa Life Sciences
- Product Type
- Drugs
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ID · 098da068-63a4-4a29-b179-10a5c13d3960