What is your estimation on the cost of a warning letter for your business? Find out which areas are affected if your company receives a warning letter from FDA.
We analysed the FDA warning letters data of the last five years with the focus on calibration and maintenance issues. The results include the annual number of warning letters, the percentage of calibration related warning letters by sector and country etc.
We reviewed and present you the inspectors’ observations of 2017 as they are provided by the FDA regarding the calibration issues.