Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA 483 to Laurus: Lapses in investiga

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

USFDA483 to Aurobindo’s Eugia US Site

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance

FDA 483 to Dr.Reddy’s cites discrepanc

FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)

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