When I read FDA Warning Letters and I do often, most take the format of telling you the observations and then indicating that this is not a complete list. However, about 10% go one step further and basically read you the riot act suggesting that you need to hire a consultant to “educate you” on the errors of your ways. These are quite common.
But I believe they went to the next level for USV Limited of Mumbai. In the 2/6/2014 WL, they even listed out 7 steps for remediation. View this as reading the riot act 7 times over. Basically there was suspicion of fraud in the data.
The link is Warning Letter
They went on as follows
Get a consultant specialising in data fraud to do the following
1.) Identify the time period when the issue occurred
2.) Identify and interview employees involved in that period
3.) Identify and interview employees who have left who were employed during the period
4.) Gather data to support what comes out of the interview
5.) Trace issues to specific managers including senior management
6.) Determine if any other offending managers are in a position to influence data integrity decisions and expand your oversight
7.) Put into place procedures to prevent recurrence and assure there are no discrepancies between what was filed and reality. Create CAPAs to remedy issues. This does not apply simply to what we found but everything in essence.
Nothing revolutionary just common sense.