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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 data integrity out of 18 overall warnings released in 2014 for quality violations. Read More
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement. Read More
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. 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 reign in large compounders. Read More
A compounding pharmacy pled guilty 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
Lax procedural documentation in quality control units topped the list of reasons why drugmakers received Form 483s in fiscal 2014, its ninth consecutive year at the top, while poor laboratory controls jumped to second place from fourth in the annual rankings of inspection observations. Read More
A compounding pharmacy pled guilty last week 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
Drugmakers may soon have to report to the FDA how they decide when to launch a CAPA investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. 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
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