New Warning Letter of the FDA with the Focus on "Data Integrity"

Recommendation

19-21 May 2021

Live Online Training: EU GMP-/FDA-compliant Sampling

Again, the focus of FDA's Warning Letter for the Chinese API manufacturer Zhejiang Medicine Co. Ltd. dated 4th August 2016 is on the lack of data integrity. Among other things, records of activities were made not at the time when they have been performed. Moreover, original data have been deleted. A number of alarming findings were discovered in the course of the FDA inspection in June 2015.

The FDA is now expecting concrete measures ("Data Integrity Remediation") from the company. For this, the FDA expressly recommended to retain qualified, external consultants. Among the measures to be taken:

A - A comprehensive investigation of the extent of incorrect data
1. An extensive plan for the execution of the investigation
2. Interviews of current and former employees to clarify the root cause of incorrect data
3. An assessment of the extent of data integrity deficits.
4. A comprehensive retrospective assessment of the performance of analytical testing.

B - A current risk assessment of the possible effects of the deficiencies identified on the quality of the medicinal products, up to the risk to patients!

C - A management strategy for the implementation of CAPA plans.

All in all, there were great concerns about the authenticity and reliability of the data produced in that company.

To find out more access the complete Warning Letter for Zhejiang Medicine Co. Ltd.