Warning letters, 483s, Recalls, Import Alerts, Audit observations
MHRA has decided to continue the extension of the validity GMP & GDP Certificates until
The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene
Baxter recalled several lots of Ondansetron injections in US for pH failure in November 2023.
FDA has approved Novartis’ Iptacopan (Fabhalta) for treatment of rare blood disease, Paroxysmal Nocturnal Hemoglobinuria
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 &
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
Apotex initiated recall of Paroxetine Hydrochloride tablets in US for failed Impurities/degradation Specifications. Apotex Corp.,USA
Sandimmune (cyclosporine oral solution) 100 mg/mL,packaged in 50 mL bottles, is indicated for the prophylaxis
Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to
