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The FDA slapped TrueCare Biomedix with a Form 483 for numerous procedural issues and violations observed during a November inspection of its facility in Gujarat, India. Read More
The FDA served U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing, cleaning and maintenance. Read More
The FDA observed various GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Read More
The firm also failed to follow its validation protocol, as the master batch record was missing details for a critical step, and a timer malfunction occurred during a demonstration. Read More
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
The FDA issued Form 483 reports to facilities in Germany, China, Mexico, South Korea, the United Kingdom and the U.S. for a range of nonconformance issues. Read More
The FDA cited issued warnings letter to drugmakers in Japan, Mexico, Australia and to three in the United States for GMP and other deficiencies. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More