OR WAIT null SECS
September 21, 2017
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
September 19, 2017
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
September 11, 2017
FDA cited Meridian Medical Technologies, a Pfizer company, which manufactures Mylan’s EpiPen, for cGMP violations that included failure to appropriately investigate defects in auto-injector components.
September 01, 2017
A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
August 30, 2017
An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.
August 28, 2017
FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.
August 23, 2017
FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.
August 18, 2017
FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
August 14, 2017
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
August 01, 2017
Research suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.