# FDA 483 - Sitec Labs Limited - March 29, 2024

Source: https://www.keypedia.com/records/483/sitec-labs-limited/7778acb6-ac5c-4082-aab0-792712673b3b

> FDA 483 for Sitec Labs Limited on March 29, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sitec Labs Limited
- Inspection Date: 2024-03-29
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sitec Labs Limited, a biopharmaceutics clinical facility in Navi Mumbai, India, was cited for failing to maintain adequate and accurate records of clinical trial related activities according to good clinical practices. The inspection revealed significant issues with demonstrating the chain of custody for investigational products and PK samples. This included storing samples in an unvalidated and unmonitored freezer without proper documentation.

## Related Documents

- [483 - 2024-06-07](https://www.keypedia.com/records/483/sitec-labs-limited/5c82b973-4f59-4cba-bac3-1c833b9311db)

## Related Officers

- [Dawn C. Olenjack](https://www.keypedia.com/people/dawn-c-olenjack/b5a18d10-cd4b-405e-9016-8f5274a33000)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd