In our February 1st Issue, we highlight a specific 483-observation concerning rejected secondary packaging materials […]
In GMP Trends Issue Number 1152, we highlight observations related to manpower limitations and the […]
As noted in our January 1st, 2025 report – some companies are overly reliant on […]
In GMP Trends Issue #1150, a noteworthy observation was reported regarding a bulk API manufacturer […]
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 […]
