483s

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 deficient failure

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

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

USFDA 483 to Jubilant cites poor OOS Inv

USFDA483 for Jubilant Roorkee cited deficient review of unexplained discrepancies, OOS (out of specifications),  deficient CAPAs. Jubilant Generics

Jubilant USFDA 483 cites poor Chromatogr

USFDA 483 to Jubilant Roorkee cited inadequate review of unexplained discrepancies, aborting dissolution testing analysis for

Jubilant USFDA 483 – Lapses QC equipme

USFDA 483 for Jubilant Roorke cited inadequacies in investigation of equipment breakdowns, error messages, alarms.