The Quality Lowdown: US FDA Warning Letters, 483 Reports Hit Poor Sterility And Lax Investigations

Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.

The Quality Lowdown

The US Food and Drug Administration continued to crack down on lack of sterility assurance, cross-contamination and poor investigations in recent inspection reports and warning letters to pharma companies.

An aging facility still churning out a former blockbuster drug as generic competition encroaches was cited for microbiological

Meanwhile, the agency criticized another firm for combining drug compounding and

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