Discussion forum for Pharma Quality events, Regulatory Actions

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

Investigation Docs Outside EDMS, Hold Ti

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January

Qvents Team
November 13, 2024

Deficient Method Validations, Aseptic ar

Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance

Qvents
June 30, 2024

FDA 483 to DRL : Issues in Analytical Va

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate

Qvents
June 24, 2024

FDA 483 to Jubilant : Data Integrity con

USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,

Qvents
April 11, 2024