Warning letters, 483s, Recalls, Import Alerts, Audit observations
Intas facility at Matoda, Sanand in India (FEI 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
Tarsus Pharmaceuticals Inc., in a statement announced FDA approval of Lotilaner ophthalmology solution 0.25% (XDEMVY™).
Verrica Pharmaceuticals Inc. is a dermatology therapeutics company developing medications for skin diseases requiring medical
EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits
Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023
EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out
Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert,
Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per
