Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Glenmark has initiated a Class II recall of 37200 bottles of Indomethacin 25mg capsules and
AstraZeneca’s TRUQAP (New Molecule Capivasertib) in combination with Faslodex (Fulvestrant) has been approved in the
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore
Danish Pharma firm Ascendis Pharma announced the European Commission approval for palopegteriparatide (Yorvipath), for treatment
