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The FDA sent a warning letter to Chinese manufacturer Guangzhou Baiyunshan for failing to follow proper cleaning, validation and storage procedures at its Guangzhou, Guangdong facility. Read More
President Trump’s proposed budget for FY 2019 calls for a major increase in budget authority for the FDA along with a significant increase in user fees. Read More
The FDA issued Wuhan Chinese Moxibustion Technology a warning letter for manufacturing adulterated products, and for quality and sanitation deficiencies. Read More
The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Read More
API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements. Read More
API manufacturer Macfarlan Smith drew a Form 483 from the FDA for failing to ensure products manufactured at its Edinburgh, Scotland facility met current good manufacturing practice requirements. Read More
The FDA flagged a problem with contaminated vial stoppers in a warning letter to Celltrion over deficiencies at its Incheon, South Korea facility, which manufactures Inflectra (infliximab-dyyb), the Ramicade biosimilar. Read More