- 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