In a recent inspection, FDA issued an observation that should unsettle any manufacturer relying on […]
In a recent FDA inspection, investigators noted that airflow visualization studies used to qualify the […]
In our most recent GMP Trends Report Issue #1176, simple labeling gaps revealed deeper weaknesses […]
A firm received the following critical 483 in response to their Stability Program failures. This […]
A firm recently received the following 483-observation relating to the absence of a quality agreement […]
During a recent inspection, FDA observed that finished product release testing sample sizes did not […]
A recent FDA inspection observation highlights an environmental qualification program failure: conducting temperature and humidity […]
FDA cited a firm for training records that failed to specify which SOP revision employees […]
FDA cited a firm for failures pertaining to labeling integrity, inspection, and storage. The 483 […]
The most recent GMP Trends Report highlights a striking observation relating to a firm’s failure […]
