# FDA 483 - JANSAT LABS PRIVATE LIMITED - February 19, 2025

Source: https://www.globalkeysolutions.net/records/483/jansat-labs-private-limited/61f95890-1318-4e8f-aded-82bad5bc9bac

> FDA 483 for JANSAT LABS PRIVATE LIMITED on February 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JANSAT LABS PRIVATE LIMITED
- Inspection Date: 2025-02-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of JANSAT LABS PRIVATE LIMITED, a contract testing lab in Hyderabad, India, revealed deficiencies in their quality control unit. The firm failed to ensure proper review of logbooks by the Quality unit and utilized an unvalidated program for critical calculations related to sample testing.

## Related Officers

- [Cecilia H. Kieu](https://www.globalkeysolutions.net/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)

Company: https://www.globalkeysolutions.net/companies/jansat-labs-private-limited/46aa85eb-9a0f-4375-a515-734563672767

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8