- Have you recently recalled a product or received a warning letter from a regulatory agency?
- Have you recently received a FDA 483 list of observations?
- Are you concerned about this happening in the near future?
In the recent regulatory environment a large number of life sciences companies have been recipients of one or more FDA 483 observations and Warning Letters. We have developed a large database of the underlying characteristics of the letters and observations. Using our PI framework and our vast experience in the details of life sciences operations, batch record analysis and investigations we can provide you invaluable help to quickly understand:
- How your recalls, letter or observations compare with others
- Potential Underlying Causes of Such Observations
- Common Aspects of Many of the Recent Regulatory Observations
- Severity of a Particular Letter or Observation Compared to Others in the Past
- Categorization of Regulatory Observations into Their Components