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FDA Issues Guidance on CMO Quality Accords

The FDA has issued long-awaited guidance on how drugmakers and their contract manufacturing partners can best use quality agreements to ensure safe and effective drugs. The guidance recommends companies establish formal quality agreements with contract manufacturers and testing labs, and that they build strong safeguards into the agreements. The guidance will be welcome news to FDA investigators, who now routinely review quality agreements during inspections but have lacked guidance on what a good agreement should contain. The guidance, at a mere 12 pages, is unlikely to resolve all issues. But it does offer the industry the agency's perspective on a number of key issues. . . .
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FDA Slams Indian Drugmaker For Moldy Facility, Falsifying RecordsFDA Slams Indian Drugmaker For Moldy Facility, Falsifying Records

The FDA slapped Indian injectable drug manufacturer Mark Biosciences Mark Biosciences with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. . . .
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Industry Worried FDA Guidance on Counterfeits Could Lead to False AlarmsIndustry Worried FDA Guidance on Counterfeits Could Lead to False Alarms

Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. . . .
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Sun Conducts Massive Recall Due to Poor Quality of APIs
Who is involved: Indian drugmaker Sun Pharma. What happened: Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. . . . keep reading
Dr. Reddy’s Discloses Accusations of Improper Packaging
Indian generics maker Dr. Reddy's Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. . . . keep reading
Baxter Recalls More Products Due to Particulates
Who is involved: Injectable drug maker Baxter Healthcare. What happened: Baxter continues to be plagued with particulate problems, recalling two lots of a dialysis solution and a lot of saline solution that is currently in short supply. . . . keep reading
Senator Urges Faster FDA Action on Drug Shortages
A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. . . . keep reading
Cubist Recalls Another Nine Lots of Cubicin
Complaints of particulates found in vials of nine lots of Cubist Pharmaceuticals’ anti-infective drug Cubicin prompted the company to initiate its second recall of the drug in as many days. . . . keep reading
FDA Slaps Second Impax Plant with a Form 483
Who is involved: Brand and generics maker Impax. What happened: Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts about the company’s plan to win approval of its Parkinson’s drug Rytary. . . . keep reading
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