Discussion forum for Pharma Quality events, Regulatory Actions

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

Environmental Monitoring Failures, Steri

In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd

Qvents
May 22, 2023

USFDA Implements ICH Q9(R1)

USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision

Qvents
May 22, 2023

USFDA 483 to IPCA, Silvassa Cites Lapses

FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at

Qvents
May 18, 2023

Pharmmedica USA, manufacturer and distri

Qvents
May 18, 2023

Astellas’
Qvents
May 15, 2023

FDA Releases Two Discussion Papers to Sp

Qvents
May 11, 2023

USFDA has issued a new
Qvents
May 11, 2023

MedinCell along with Teva gets approval

Qvents
May 4, 2023

Laurus Labs receives in-principle approv

Qvents
May 4, 2023

Teva USA is recalling thirteen lots of F

Qvents
April 30, 2023