Why do good manufacturing operations have bad inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures; to SOPs and QC procedures; and to complaint handling and CAPA investigations. But in many,... Read more

Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. Still, many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester... Read more

There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes to regulated manufacturing operations, the FDA’s rule of thumb is... Read more