Topic: Form 483

FDA inspectors found that AbbVie didn’t include historical death complaints for the same lot in its search system for its all-too-important drug Humira.

The FDA has issued a complete response letter to partners Biocon and Mylan for their version of Sanofi’s blockbuster Lantus insulin.

The FDA has OK’d the Daewoong manufacturing plant that will make Evolus’ Botox rival but rejected Evolus' biologic over its manufacturing design.

Indian drugmaker Dr. Reddy’s said that following an inspection, the FDA issued a Form 483 to its API Hyderabad Plant 1, citing four issues.

Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which has had another plant cited by the FDA.

Shionogi’s flu drug won Japanese approval; Sun Pharma's Halol plant was cited by the FDA; EpimAb hired a top Novartis researcher as CMO; plus more.

After years of effort and a couple of reinspections, India’s Sun Pharma has been unable to satisfy the FDA's expectations for its key plant.

Takeda made two R&D deals, China's crackdown on pollution causes pharma supply issues, Merck KGaA plans production expansions in Asia.

Biocon and Mylan have hit another manufacturing snag on their march toward an FDA nod for their copy of Sanofi's blockbuster Lantus.  

A recently released FDA document shows that Pfizer's troubled fill-finish plant in Kansas was cited for continuing to repeat mistakes already cited by the FDA.