Drug GMP Report

The FDA is asking Novartis for a comprehensive, global manufacturing assessment after it sharply scored the company for multiple repeated quality failures at plants operated by its Sandoz subsidiary.

Indian generic-drug giant Ranbaxy Laboratories entered into a consent decree with the FDA to resolve lingering manufacturing problems at two plants.

The FDA and European Medicines Agency (EMA) plan to step up cooperation on manufacturing inspections this month, moving from information sharing and joint inspections to outright reliance on one another’s results.

A federal judge is allowing an investor lawsuit to move ahead against Johnson & Johnson (J&J) over its transparency on quality control failures that led to market withdrawals of Motrin and OTC children’s medications.

Federal investigators are increasingly resorting to unannounced visits to the homes of drugmakers’ employees to question them during investigations, and companies should take steps to prepare if facing government scrutiny, an industry attorney says.

Hospira, still struggling with GMP issues at its Rocky Mount, N.C., and Austin, Texas, facilities, has received a Form 483 for lacking documented validation processes at a Boulder, Colo., plant.

Nephron Pharmaceuticals may have inadvertently distributed batches of asthma medicine befouled by Bacillus bacteria, an FDA Form 483 states.

Wyeth’s Richmond, Va., plant failed to submit timely alerts for one or more distributed batches of drugs observed by customers as not up to specification, an FDA Form 483 states.

Drugmakers befuddled by manufacturing failures, such as product contamination by microorganisms, are urged to perform risk assessments and take preventive action, the FDA says.

The FDA made good last year on previous promises to tighten up loose links in the global drug supply chain while addressing criticism that agency decisionmaking is unduly opaque.

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.

Gordon Richman, vice president of Strategic Compliance Consulting, and general counsel of EduQuest, answered questions about how drugmakers should evaluate and respond to FDA Form 483s.

The FDA warned Akzo Nobel Chemicals’ Mexican manufacturing facility and placed the plant under an import alert after it failed to investigate and prevent shipment of contaminated products.

Drugmakers need incentives from Congress and the FDA to create improved manufacturing methods that would help alleviate ever-increasing drug shortages, an industry expert tells lawmakers.

The FDA is suing drug- and dietary supplement-maker Syntec and ordered U.S. marshals to seize its products, citing manufacturing violations and false and misleading health claims.