Discussion forum for Pharma Quality events, Regulatory Actions

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

Aarti Drugs USFDA 483 Flags Unique Chall

Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India

Qvents Team
December 16, 2024

USFDA 483 to Biocon Points Lapses in Equ

Biocon Visakh (Biocon Biosphere Limited, FEI 30221 25340) was inspected by USFDA investigator  Brandy N

Qvents
August 14, 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

USFDA 483 to Torrent Pharma cites defici

Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec

Qvents
January 5, 2024

US Repackager Spectrum gets USFDA 483 wi

Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H

Qvents
October 19, 2023

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

IPCA USFDA 483 Highlight Criticality of

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

Qvents
May 27, 2023

USFDA 483 Flags Dupont for Lapses in Avi

USFDA issues Warning letter to DuPont Nutrition USA Inc., Newark, Delaware facility (FEI 3013947845) for

Qvents Team
January 23, 2023