FDA withdraws approval Oxandrin (Oxandro
Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023
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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
