Author: Qvents

USFDA 483 to Lupin Cites Lapses in Envir

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

USFDA 483 to Lupin Flags Gaps in Change

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

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

FDA Warning Letter to Glenmark Cites Lap

Warning letter / Glenmark, Goa, India /FEI 3004672766 / MARCS-CMS 637314/ 320-23-04/ NOVEMBER 22, 2022/

Recall / Accord Healthcare /Daptomycin f

Accord healthcare recalled from US market Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial

Warning letter / DuPont Nutrition USA In

USFDA Warning letter to Dupont cites inadequate evaluation of complaints, even though the Firm received several

FDA Warning letter to Dupont cites Inade

USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact  evaluation. The warning letter