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 website claimed the product could be used with chemotherapy for the “clinical dietary management of the metabolic imbalances associated with glial tumors. Read More
The FDA warned a French drug contract testing laboratory following a September inspection that revealed deficiencies in testing practices and discrepancy investigations. Read More
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Read More
During a September inspection at the firm’s Hong Kong facility, the inspector noted that the firm did not test all batches of over-the-counter topical liquid analgesics before batch release. Read More
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Read More
Four firms in Switzerland, the United Kingdom and the U.S. were hit with Form 483s for having inadequate cleaning and sanitization procedures, in addition to batch record issues. Read More
The FDA warned five firms in South Korea, China and Germany for various GMP violations, including problems with sanitation, facility procedures and complaint handling. Read More
The FDA issued Kath Khemicals a Form 483 after an inspection of its Sterling Heights, Michigan facility revealed problems with batch reviews, product testing and cleaning, among other deficiencies. Read More
The FDA hit Chinese firm Zhejiang Ludao Technology with a warning letter after an August inspection revealed significant testing issues at its Taizhou, Zhejiang facility. Read More
As part of its heightened focus on data integrity the FDA has increased the sophistication of its inspections to identify hard-to-find data violations, according to a former CDER official who shared data integrity compliance tips in an FDAnews webinar Wednesday. Read More