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FDA 483s Warning Letters And Enforcement Trends
Topic 1: Enforcement Trends
- 2019 FDA Enforcement activities
- FDA Hot Topics
Topic 2: Review GMP Violations
- 483 Observation trends
- Warning Letter trends
Topic 3: Managing Inspections to minimize the risk of escalation
- Avoiding audit management mistakes
Overview of the webinar
The fiscal year 2019 saw the most warning letters issued by the FDA to makers of finished pharmaceutical products in recent history. During the last 12 months, a total of 81 warning 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 reveal a continuation of a trend that’s been running for years: lapses in meeting basic GMP requirements.
Who should attend?
CGMP professionals:
- Quality Assurance
- Regulatory Affairs
- Production
- Engineering & Validation
Why should you attend?
- Enforcement trends: 2019 FDA enforcement activity — 483s and warning letters — vs. prior years
- Most prevalent targets of FDA inspections
- GMP violations are most often cited in 483s and in warning letters
- Managing inspections to minimize the risk of escalation
- How lawsuits are born: The role that FDA enforcement actions play
Faculty - Ms.Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.