The following 483 describes an organization denying FDA Investigators entry into a warehouse storing APIs, […]
FDA cited a facility for failing to adequately test in-process materials for quality after extended […]
FDA recently cited an organization for egregious data integrity mistakes. Throughout time, staff developed workarounds […]
Following a previous FDA inspection that led to an issued 483, an organization implemented corrective […]
FDA recently cited a firm for failing to establish and follow written procedures for the […]
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 […]
