Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

USFDA 483 / Sun Pharma, Mohali, India /

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

Qvents
May 3, 2023

Backdating and DI issues lead to Consent

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

Qvents
May 1, 2023

Intas USFDA 483 cites Data Integrity, to

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

Qvents
April 18, 2023

FDA Warning Letter to Glenmark Cites Lap

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

Qvents
April 18, 2023

USFDA Warning letter to Glenmark Cites C

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

Qvents
April 18, 2023