CGMP Resources

At PCGI, we strive to be the 3rd party Regulatory Compliance Consultant firm of choice for Pharmaceutical companies around the globe. Our core value is that we believe people with passion can  change the world.  To be and think differently. Our goal is to support Pharma companies establish compliance that is sustainable.  

In 2024, many firms received warning letters from the FDA approximately 6 months after inspections, often due to incomplete responses to 483 observations. While receiving a warning letter is not ideal, it sheds light on areas for improvement, emphasizing the importance of addressing CGMP deficiencies effectively. The FDA may deem responses inadequate if they lack sufficient details on corrective action plans. To avoid such issues, firms should focus on evaluating processes, assessing quality impacts on products, and implementing preventive measures for future compliance.
At PCGI, we assist clients in achieving compliance by translating regulations into practical solutions.

In the 2024 fiscal year (Oct 2023 to Sept 2024), the FDA conducted a total of 1546 drug inspections. Among these, 1170 were classified as NAI, 358 as VAI, and 18 as OAI. The key citations highlighted violations such as procedures not being fully followed, absence of written procedures, inadequate laboratory controls, and insufficient investigation of discrepancies or failures.
Transitioning into the initial two months of fiscal year 2025 (Oct & Nov 2024), there were 64 inspections conducted. Out of these, 22 were categorized as NAI while 42 were marked as VAI. The primary citation observed during this period pertained to the absence of written procedures.
At PCGI, our focus lies in supporting clients to establish regulatory compliance vigilance programs. These programs are designed to analyze inspection data and trends, playing a vital role in a comprehensive surveillance and inspection readiness strategy.