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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
The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues. Read More
The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate testing and poor quality controls. Read More