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The FDA’s Office of Generic Drugs released its annual report for 2018, highlighting a steady increase in first-time generic approvals and the green lighting of more than 1,000 generic drugs. Read More
The FDA issued a warning letter to an OTC drug manufacturer in Catalonia, Spain, for inadequate testing of released drug products and incomplete batch records. Read More
Vipor Chemicals drew a warning letter from the FDA for CGMP violations observed during an inspection last year at its facility in Vadodara, Gujarat — including the use of an API supplied by a manufacturer on an FDA import alert. Read More
The FDA cited OTC and prescription drugmaker Woodfield Pharmaceutical of Houston, Texas for non-compliant batch reviews, complaint handling and quality control at its facility. Read More
Employees were seen touching equipment or other surfaces outside of the ISO 5 area with gloved hands and then conducting aseptic processing in the cleanroom. Read More
The FDA hit Hangzhou SunKing Nonwovens with a warning letter, citing the manufacturer for numerous quality violations at its Hangzhou, Zhejiang facility. Read More