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A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More
The FDA issued a warning letter to Chinese drugmaker Guangdong Zhanjiang Jimin Pharmaceutical following a May inspection of its Guangdong Province facility. Read More
A worker at an Idaho compounding pharmacy used “a worn plastic store club card” to scoop a powdered drug into empty gelatin capsules, in violation of federal regulations, the FDA said in a warning letter. Read More
The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board. Read More
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More
The FDA cited a drug outsourcing facility in Bethlehem, Penn., for numerous compliance problems including inadequate computer security and lax labeling practices. Read More
The FDA cited an Illinois provider of home infusion therapy for failing to meet sterile production standards, according to a warning letter from the agency. Read More
UK regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination. Read More