FDA 483s, Warning Letters And Enforcement Trends

Description

The outcome of regulatory inspections is critical to an organization’s success. The FDA performs inspections to check that companies are maintaining compliance with applicable regulations and quality standards. Though you do your best to avoid it, receiving a 483 or Warning Letter is inevitable. It’s important to take the observations very seriously, because you only have 15 days to submit the subsequent responses.

But ensuring that you are aware and understand what the regulatory agency is expecting in the response can be a challenge.  What should you include? What are the risks of not submitting an appropriate response?

This 90-minute course will discuss the importance of developing and submitting a robust, timely response to FDA 483 observations or warning letters; as well as, educate the audience on the essential elements of a thorough response.  Additionally, this course will review the proper structure of the response to ensure the regulatory agency’s expectations are met and the submission process.

Why Should You Attend:

Publicly available warning letter and inspection observation data provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities within your quality system.

Fiscal year 2019 saw the most warning letters issued by FDA to makers of finished pharmaceutical products in recent history. During the last 12 months, a total of81warning letters were issued to finished product manufacturers worldwide,the most since the fiscal year 2015. This is in contrast to the number of warning letters sent to API manufacturers, which has fallen since peaking in 2017. 

Over half (46 to be exact) of the 81 warning letters were issued to companies located in the United States. The most frequently cited GMP violations in warning letters concern basic requirements.

In addition to an increase in Warning Letters, the frequency of FDA 483 observations issued to pharmaceutical companies has continued to rise over the past few years.

In the fiscal year 2019, there were a total of 779 483 observations issued for drug inspections compared to 716 in 2018, 694 in 2017, and 691 in 2016.

The specific issues contained within these recent warning letters and 483 observations reveals a continuation of a trend that’s been running for years: lapses in meeting basic GMP requirements.

Learning Objectives:

At the completion of this session, you will be able to:

• Identify timelines and potential regulatory outcomes of not submitting an appropriate response
• Review the components necessary to develop a thorough response
• Utilize a response checklist
• Evaluate recent Regulatory observations and review associated responses
• Recognize the process for submitting the response to the regulatory agency
• Discuss when and how to provide follow-up updates to the regulatory agency post the initial response
• Develop post response outcomes
• Enforcement trends: 2019 FDA enforcement activity  - 483s and warning letters - vs. prior years
• Most prevalent targets of FDA inspections
• GMP violations most often cited in 483s and in warning letters
• Managing inspections to minimize risk of escalation
• How lawsuits are born: The role that FDA enforcement actions play

Who Should Attend?

• cGMP professionals:
•  Quality Assurance
•  Regulatory Affairs
•  Production
•  Engineering and Validation