Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
IPCA Dhar facility was inspected by USFDA in June 2023. The site (FEI 3007574780) was
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
