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TOP-10 Observation related to calibration
FDA

TOP-10 Observation related to calibration

Ashish Gupta December 17, 2023

Calibration work sheets/Annexure are missing  No formal procedure for out of calibration and change management.   Calibrations not done as per schedule. Doc…

USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit
FDA

USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit

Ashish Gupta December 12, 2023

USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit Torrent Pharmaceuticals Ltd on Tuesday said the US health regulato…

Warning Letter Cipla Ltd Pithampur Unit (17/11/2023)
FDA

Warning Letter Cipla Ltd Pithampur Unit (17/11/2023)

Ashish Gupta November 30, 2023

The recently warning letter issued to CGMP Violation from USFDA Inspection of  Cipla Ltd. Pithampur (MP) manufacturing site from 06/02/23 to 17/02/2023 Detai…

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