In a recent FDA inspection, investigators noted that a firm failed to conduct hold time […]
During a recent FDA inspection, the CEO of a pharmaceutical firm voluntarily stated that the […]
During a recent FDA inspection, a medical device manufacturer was cited for failing to implement […]
FDA cited a firm for resuming sterile filling after a 5-week shutdown without conducting a […]
An alarming and recent 483 highlights FDA’s continued scrutiny of data integrity issues concerning the […]
In most compliance training programs, employees are taught what to do: follow SOPs, complete forms, […]
A recent FDA observation makes it painfully clear that failure to control labeling and packaging […]
A recent FDA 483 observation highlighted a shortcoming by a firm’s QA team in their […]
In our latest GMP Trends Report Issue #1158, a particularly concerning observation was noted regarding […]
Our latest GMP Trends Report Issue #1157 highlights troubling patterns that underscore the ongoing need […]
