USFDA issued warning letter to Semler research, Banglore :Fact and Learn

:Photo upload from Semler official website.

In Apr 2016 USFDA declare the inspection for the submitted study in Semler, Banglore.

According to the information , USFDA select the 30 projects for audit to check the data intigrity of the projects.
During facility round one lead inspector found excel sheet on data server of one employees regarding the concentration data of the particular projects.

According to the information the spreadsheet contain concentration data regarding Test and reference product of the submitted projects. That employee even don't know what he save on server and what was the impact.
The spreadsheet contain the subjects number that plasma samples were replaced with already analysed other subjects sample.
Site was not disclose the name of the employee who save the spreadsheet. USFDA verify the subject concentrations data and existing data and found that significant differences in 90% CI value.

Image source: Google image.

USFDA was questioning of all study (NDA, ANDA) related results that were submitted to the USFDA in past.

During this USFDA issued warning letter (Form 483) to the Semler for the sample replacement issue.
However, the agency is requiring that sponsors of approved applications repeat the bioequivalence/bioavailability studies using a company other than Semler.

Dear members, what we learn from the Semler issue?

A. Do not manipulate any data. It's should be define in the quality policy of the company . For Quality system every employee is responsible and have to flow in your blood as well as in act. It should be reflect from your act so no one has to dare to do falsification of the data even your will think before doing like this.
If anybody have forcing you to do manipulate any data then report to the higher authority as well as to mmanagement. They will definitely help you out.

B. "Ethics" is most important things when you are working with CRO.

Because you can't work without considering ethics that whatever I do is the compliance with GxP or not ?
If I am doing any manipulation (you don't have to do) then what will happened if  this manipulation is  found by any regulatory agency and what will ther impact on the organization?
This type of questioning asked to yourself again and again like a self assessment.

If every employee will do work like that then no one have any questioning on your work. Please oblong your work. Management has to awarded if any employee troubleshoot any problem or any employee has report directly to their HOD or management if anyone forcing them to do any corrections in original generated data.

C. Do not save any unwanted files/ folder in the server as well as on desktop. You don't have any personal folder within your circle because company is company and personal work is personal.
Always clean your recycle bin at every interval.

Think over it guy's... Feedback any more suggestions.

Thank you.

Untitled Letter USFDA (Pdf)