Operators are hit hard by breakage problems and strike out on FDA inspections.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

They may have seemed harmless at first, but these ideas took a big bite.

Customers complaining lead to some serious explaining.

WFI system deficiencies and damp tax records cause problems for two plants

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?

If not properly monitored, filters and plastic bags can keep back more than they should.

If at first the product fails, then inspect, inspect again

Process efficiency is measured not only by what is kept, but also by what is thrown away.