# FDA 483 - Sitec Labs Limited - June 07, 2024

Source: https://www.globalkeysolutions.net/records/483/sitec-labs-limited/5c82b973-4f59-4cba-bac3-1c833b9311db

> FDA 483 for Sitec Labs Limited on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sitec Labs Limited
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Sitec Labs Limited in Navi Mumbai received a Form 483 for significant data integrity and documentation issues during bioanalytical studies. Observations included unjustified re-injection of acceptable study runs, inadequate logbook documentation for sample movement, and discrepancies between bioanalytical reports and source documents regarding acceptance criteria failures. These issues indicate a lack of robust quality control and data management practices.

## Related Documents

- [483 - 2024-03-29](https://www.globalkeysolutions.net/records/483/sitec-labs-limited/7778acb6-ac5c-4082-aab0-792712673b3b)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sitec-labs-limited/5ad3197e-7fdd-4d37-b539-3399da5eeeac

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321