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 […]
In the most recent GMP Trends Report, one firm was cited for failing to adequately […]
FDA investigators issued a 483 to a firm that generated Certificates of Analysis (COAs) for […]
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 […]
