USFDA 483 to Laurus: Lapses in investiga
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance
FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)
Torrent’s Chhatral, Gujarat facility (FEI: 3012740315) was inspected by USFDA (Investigator Yvins Dezan) in Dec
USFDA inspected Laurus Synthesis, Visakh facility in India (FEI: 3011524794) in Dec 2023 by investigators
Dr.Reddy’s Laboraties (DRL) site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S
The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)
FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,
Dr.Reddys Laboratories (DRL) Medchal, Telengana site was inspected by USFDA (Investigators Saleem A Akhtar &
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore