Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

Qvents
June 20, 2023

Document Control Deficiencies – US

USFDA 483 to UCB Belgium cites fundamental gaps in document control  – uncontrolled forms for

Qvents
June 3, 2023

IPCA USFDA 483 Cite Lapses in Data Integ

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

Qvents
June 1, 2023

IPCA USFDA 483 Flags Delayed Failure Inv

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

Qvents
May 29, 2023

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

Lupin USFDA 483 cites deficient failure

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

Qvents Team
April 22, 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

Qvents
April 21, 2023

USFDA 483 to Cipla cites deficiencies in

USFDA inspection of Cipla Pithampur site ( FEI 3008581988) by Inspectors Saleem A Akhtar & 

Qvents
April 19, 2023