We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or else restrict production to penicillin. Read More
The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Read More
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