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 […]
In a recent FDA inspection, a company was cited for failing to utilize actual production […]
Verification of lab data is a crucial aspect of ensuring compliance with established specifications and […]
21 CFR 211.25 specifies employee training and education must have “sufficient frequency to assure that […]
A robust corrective and preventive action (CAPA) system is critical for maintaining compliance and product […]
A recent FDA inspection at a pharmaceutical manufacturing facility revealed serious deficiencies in the firm’s […]
