Incomplete batch records and poor testing of finished drug products resulted in a Form 483 for New York drugmaker Cerovene. Read More

Stason Pharmaceuticals received a Form 483 for not properly following up on deviations and storing equipment in a “haphazard manner.” Read More

The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects. Read More

The FDA has hit two compounding pharmacies with warning letters for quality violations and failure to have prescriptions for products they were compounding. Read More

Japan’s national drug regulator has asked drugmakers to submit information on stability monitoring and water purity, in addition to existing requirements, when they apply for mandatory post-approval GMP inspections. Read More

Ranbaxy’s regulatory woes deepened Thursday as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection. Read More

Proposed international guidelines on metal impurities in finished drugs may be impossible to meet because they lack specificity and are impractical for suppliers, drugmakers say. Read More

Poor investigations into batch failures and lax procedural documentation were the top reasons drugmakers received FDA Form 483s in 2013. Read More

In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More