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FDA Commissioner Stephen Hahn said Friday that the agency will resume domestic inspections this month using a new risk assessment system developed in response to the pandemic. Read More
The FDA issued a warning letter to active pharmaceutical ingredient (API) manufacturer Vega Life Sciences for violations of good manufacturing practices (cGMP) at its facility in southern India. Read More
The FDA cited Takeda biotech subsidiary Baxalta for a host of violations at its Thousand Oaks, California facility, including GMP lapses that could lead to product contamination. Read More
The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Read More
Canadian sterile drug manufacturer Viatrexx was hit with an FDA warning letter for serious violations of aseptic practices observed during an agency inspection. Read More
Cosmaceutical Research Lab was hit with an FDA warning letter for serious violations uncovered during an inspection of the firm’s manufacturing facility in British Columbia, Canada. Read More
The FDA hit Tokyo-based drugmaker Takeda with a warning letter after an inspection revealed that manufacturing problems for its drug Natpara (parathyroid hormone) uncovered last year were still not resolved. Read More
The average inspection score for pharma manufacturing sites in fiscal 2019 dropped slightly from the year before, but scores for over-the-counter and homeopathic products significantly dragged down the global average, says a new FDA report. Read More
The FDA hit Apertus Pharmaceuticals with a Form 483 for data integrity lapses and other good manufacturing practice (GMP) violations observed during an inspection of its St. Louis, Missouri facility. Read More
The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Read More