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’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
A slew of observations related to cleanliness and sterility at Patheon Manufacturing Services’ Greenville, N.C., facility have resulted in a Form 483. Read More
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More
The FDA warned a Chinese maker of active pharmaceutical ingredients over data integrity lapses and other serious deviations from current good manufacturing practice. Read More
A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More