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 blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility. Read More
The FDA hit OTC oral gel manufacturer Europharma Concepts with a warning letter after finding significant CGMP violations at its facility in Clara, Ireland. Read More
The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Read More
The FDA issued a Form 483 to Noven Pharmaceuticals after observing numerous problems at the transdermal drug manufacturer’s Miami, Florida facility. Read More
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Read More
The FDA issued a warning letter to Jilin Shulan after an inspection of the firm’s Shulan City, Jilin Province facility revealed significant GMP deviations for active pharmaceutical ingredients. Read More
The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials said Friday. Read More