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The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems. Read More
The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites and database changes made after an initial database lock and study unblinding. Read More
British authorities have cited a U.S. drugmaker and an Indian drugmaker in recent weeks over multiple critical GMP violations at their facilities. Read More
The FDA has continued to hammer manufacturers with Form 483 citations, as evidenced by three in recent months tackling everything from sterility issues and data integrity to lax recordkeeping. Read More
The FDA has cited five U.S.-based drug compounders in as many weeks, with most of the complaints focusing on sterility issues, although questions of adulteration and issuing unapproved drugs also surfaced. Read More
The FDA has stepped up its enforcement efforts in Taiwan and mainland China in the past month, issuing warnings to two Taiwanese drugmakers and two Chinese companies. Read More
The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations. Read More