Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Cipla Patalganga USFDA 483 highlights Cl

USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with

USFDA 483 to Dr.Reddys (DRL) : Cleaning

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

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

US Repackager Spectrum gets USFDA 483 wi

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

Four Indian Pharma sites issued Warning

Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas

IPCA USFDA 483: Poor Laboratory controls

IPCA Dhar facility was inspected by USFDA in June 2023. The site (FEI 3007574780) was

Intas FDA 483 cites Manipulation of reco

FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection

Eleven observations in USFDA 483 to IPCA

IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023