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A compounding pharmacy pled guilty recently to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More
Manufacturers are urging the FDA to ax three proposed quality metrics related to annual product reviews that would measure a facility’s quality culture, claiming they are too burdensome, unnecessary and confusing. Read More
The European Union has banned imports of Ranbaxy’s injectable antibiotic cephalosporin following an inspection by German regulators who found the company’s Dewas, India, facility was not in compliance with GMPs. Read More
In 2014 the FDA laid the groundwork for an unprecedented overhaul in the next few years in how the agency will measure pharmaceutical quality and conduct inspections. This is a look back at 2014 and the year ahead. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
A Japanese active pharmaceutical ingredient manufacturer received a Form 483 for poor validation of its manufacturing methods and supplier controls. Read More
The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite the issue out of 18 overall warnings issued for quality violations as of late December. Read More
The Justice Department has charged two people with murder and 12 others with serious crimes over alleged manufacturing violations at the New England Compounding Center (NECC) that led to 64 deaths due to meningitis and sparked a federal law to rein in large compounders. Read More
The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. Read More
The FDA last week issued its 12th warning letter in 2014 for data integrity violations, out of 18 total warning letters released over good manufacturing practices, with foreign facilities drawing most of the criticisms. Read More