In a recent FDA inspection, a medical device manufacturer was cited for failure to conduct […]
The latest observations from GMP Trends Report #1148 revealed a series of significant compliance gaps […]
Written complaints have historically been prioritized and more scrutinized by industry, viewing them as more […]
A recent inspection revealed a concerning discrepancy between retain samples and the actual marketed products, […]
In a recent 483, a relabeler was cited for failing to have lot numbers and […]
A medical device firm recently received a 483 from FDA for failing to integrate their […]
Recent 483 observations make it clear that FDA expects a “Belt and Suspenders” approach when […]
A recent FDA Form 483 observation highlights the absence of robust quality agreement between a […]
A finished dose pharmaceutical firm recently received a 483 for failing to control for changes […]
When it comes to cleaning validation for pharmaceutical manufacturing equipment, having proper scientific justification for […]
