# FDA 483 - Analys Lab Private Limited - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/analys-lab-private-limited/a08066ec-addd-4d21-94bc-eb4a7c93f6ab

> FDA 483 for Analys Lab Private Limited on December 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Analys Lab Private Limited
- Inspection Date: 2024-12-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Analys Lab Private Limited (TIE Campus) in Medchal Malkajgiri, India, a control testing laboratory, was cited for deficiencies in computer system controls. The inspection revealed a lack of user privilege challenges in LabSolutions software, allowing unauthorized deletion of data, and inadequate audit trail review procedures. These issues indicate significant concerns regarding data integrity and control over electronic records.

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.globalkeysolutions.net/companies/analys-lab-private-limited/58c401aa-e098-4a48-8ad5-7ead3744c718

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