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The FDA plans to consolidate its 16 districts overseeing pharmaceuticals imports into either four or five districts under a reorganization plan that aims to make inspection policies and procedures more uniform regardless of port of entry. 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
King Pharmaceuticals received a Form 483 after agency investigators discovered problems with damaged equipment and cleanroom suits filled with holes. 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
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More