JANSAT LABS PRIVATE LIMITEDFebruary 19, 2025

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

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Record Details

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.

Company: JANSAT LABS PRIVATE LIMITED
Inspection Date: February 19, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Cecilia H. Kieu

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ID · 61f95890-1318-4e8f-aded-82bad5bc9bac