Warning letters, 483s, Recalls, Import Alerts, Audit observations
Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). Aurobindo
Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,
Several manufacturers of OTC drug products including mouthwash, toothpaste, topical analgesics, Sunscreen products, Hand Sanitizers
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293.
Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas
Intas facility at Matoda, Sanand in India (FEIÂ 3004011473) was inspected by FDA investigators Jose E
Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets
Lupin has received correspondence from the US FDA that Lupin has addressed the concerns raised
