Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Insanitary Conditions, Non-Aseptic Pract

USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA

USFDA 483 / Natco Pharma India/ Oct 2023

Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem

Natco Pharma USFDA 483 Lists Eight Obser

Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA Inspected UCB Farchim site at Bulle, Switzerland (FEI 3005023799) in June / July 2023.

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

FDA 483 to UCB Switzerland cite gaps in

USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA.

USFDA 483 to Panacea Biotec Cites Inadeq

Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd

US Repackager Spectrum gets USFDA 483 wi

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

Warning letter / Medgel / July 2023 / In

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Biocon Malaysia USFDA 483 Cites Inadequa

Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,