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 warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations. Read More
A proposed overhaul of FDA regulations would require the agency to update GMP regulations and guidances with modern manufacturing techniques. Read More
Most drugmakers bend over backwards to comply with GMPs by setting up reliable quality systems and going by the book. But they still get chided by the FDA for poor quality goods produced outside their facility, one expert says. Read More
Luitpold Pharmaceuticals was chided by the FDA for failing to properly investigate how severe roof leaks in 2013 and 2014 affected production. Read More
Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations. Read More
Ariad Pharmaceuticals failed to submit a slew of adverse event reports within the 15-day deadline and follow the risk evaluation and mitigation strategy for its blockbuster leukemia drug Iclusig, prompting a 483.
Read More
In a 46-page draft guidance released last month, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
A Japanese active pharmaceutical ingredient manufacturer received a Form 483 for poor validation of its manufacturing methods and supplier controls. Read More
The FDA barred beleaguered drugmaker Ipca Laboratories from shipping drugs to the U.S because of good manufacturing practice violations — the 27th time the agency has cracked down on GMP violations at Indian drug facilities in the last two years. Read More
In a 46-page draft guidance released Monday, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
The FDA is considering a new inspections scoring system that would, for the first time, recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations. Read More