Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Issues Warning Letter to Global Ca

Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in

Qvents
February 17, 2025

Global Calcium USFDA 483: Critical Data

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection

Qvents Team
September 17, 2024

USFDA 483, Sun Pharma: Lapses in Chromat

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

Qvents
May 8, 2023

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