Author: Qvents

USFDA Warning letters, 483s, WHO Alerts

Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality

USFDA 483, Sun Pharma: Lapses in Chromat

USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Chromatographic integration and

USFDA 483 / Sun Pharma, Mohali, India /

USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Product Quality Reviews

Backdating and DI issues lead to Consent

USFDA 483 / Sun Pharma, Mohali, India / FEI 3002807979 / USFDA Investigators: Justin A

USFDA 483 to Lupin Cites Lapses in Envir

USFDA 483 / Lupin, Pithampur, India / FEI 3007549629/ Inspection Mar 21 – Mar 29, 2023

USFDA 483 / Lupin, Pithampur, India / F

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites deficiencies

Lupin USFDA 483 Cites Lapses in OOS Inve

USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites deficiencies

USFDA 483 to Cipla cites deficiencies in

USFDA inspection of Cipla Pithampur site ( FEI 3008581988) by Inspectors Saleem A Akhtar & 

Intas USFDA 483 cites Data Integrity, to

USFDA Inspection of Intas, Matoda, Sanand facility in India (FEI 3004011473); from 22 November 2022 to

Recall / Event ID: 91441/ Recall Number:

Macleods recalled 10052 bottles of Levofloxacin USP 500mg tablets in January 2023 due to mismatching