Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 to Torrent Pharma cites defici

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

Laurus USFDA 483: Lapses in investigatio

USFDA inspected Laurus Synthesis, Visakh facility in India (FEI: 3011524794) in Dec 2023 by investigators

USFDA 483 /Dr.Reddys (DRL) / October 202

Dr.Reddy’s Laboraties (DRL) site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S

USFDA 483 to Dr.Reddys (DRL) : Cleaning

The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)

FDA Untitled letter to Novartis: Signifi

FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,

USFDA 483 to Dr.Reddys (DRL) Cites Clean

Dr.Reddys Laboratories (DRL) Medchal, Telengana site was inspected by USFDA (Investigators Saleem A Akhtar &

Cipla Warning letter cites gaps in Compl

The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore

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