Topic: FDA warning letter
The FDA hit United Exchange Corp. with a warning letter, citing the company for a number of “significant” violations with its quality-control systems.
Gilead oncology EVP Riva joins Glenmark spinoff as CEO; Biocon's biosimilar plant dinged by FDA; Shionogi licenses Akili's digital therapeutics.
The first FDA drug marketing warning letter of the year goes to ... a drug that’s not yet approved.
Lupin has indicated it has received another FDA warning letter as regulatory issues continue to pile up for the Indian drugmaker.
The FDA has picked apart the process of a Jubilant solid-dose plant in India and criticized it for repeating mistakes.
Pfizer is closing a Hospira plant in India, but the FDA still issued a warning letter for a list of serious violations it uncovered last year.
The FDA has again lashed out at a Canadian company that it has been feuding with for years for helping U.S. consumers get drugs on the cheap.
The FDA has issued a warning letter to a Florida CMO that it says has dirty equipment, poor storage methods and questionable record keeping.
The FDA has slapped a Teva plant in Florida with a warning letter for issues that have affected the dosing of a schizophrenia drug.
Pfizer is responding to a demand from a U.S. Attorney's office for records on EpiPens it manufactured for Mylan that failed during emergencies.