FDA has published the USFDA 483 issued t
Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
In May 2023, Sun Pharma initiated recall of two lots of antidepressant drug Bupropion Hydrochloride
USFDA has granted full approval for Pfizers Paxlovid, first Oral antiviral for COVID; This is
FDA has approved Xacduro injection (Durlobactam, a new molecular entity in combination with sulbactam) for
In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd
USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision
FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at
