The QMN Weekly Bulletin

Nephron Pharmaceuticals, a Fla.-based drugmaker, was handed a Form 483 after an FDA inspection found it failed to fully review unexplained discrepancies or failures of batches of albuterol sulfate solution to meet specifications.

The Justice Department received $3 billion from the healthcare industry in 2011 due to its stepped-up enforcement campaign to curb off-label marketing and violations of the False Claims Act.

As devicemakers struggle to fine-tune corrective and preventive action (CAPA) procedures, many don’t make it and are snagged during FDA inspections.

Every day brings new ways to use social media.

The FDA has issued a warning letter to Johnson & Johnson subsidiary Animas for repeated failure to report adverse events with its insulin pumps.

Concerned about the upward trend in supplier quality issues, the FDA is considering agency-wide guidance to clarify manufacturers’ responsibilities for outsourcing, an agency official says.

A recent inspection of Pro-Paks’ Middletown, Conn., plant found a lack of formal documentation for sterilization validation and re-validation processes for production of Lasik surgical kits.

The FDA is advising healthcare providers to be on the lookout for fake cancer drugs, after the agency learned of U.S. clinics receiving promotions for unapproved injectables from third-party sources.