This FDA warning letter issued to API manufacturer Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. on 19 April, 2018 is based on an FDA inspection which took place in October 2017.
The FDA inspection revealed that the electronic HPLC and GC data of several analyses could not be provided. Furthermore, analytical data had been deleted. According to the company, this data had been deleted by accident and could not be provided anymore. From the FDA's perspective, the company could not demonstrate how the deletion of data is to be prevented in the future.
It was criticised during the FDA inspection that the Audit Trails of the electronic laboratory instruments were not functioning. This had already been criticised by the FDA in an earlier FDA inspection from March/April 2015. Audit Trail had not been implemented by the company since then. What's more, the FDA inspection from April 2018 showed that no specific corrective measures had been taken.
As a corrective measure, the FDA now dictates that the company must adopt comprehensive measures to eliminate the root cause of their data integrity errors, including evidence that the extend and depth of the current action plan complies with the findings of the investigation and risk assessment.
Lijiang Yinghua Biochemical must state whether the persons responsible for data integrity will actually be able to properly handle cGMP related data in this company.
The repeated failures showed that the monitoring and control of drug production in the facility is insufficient. The company must now elaborate on how they plan to make sure that all requirements will be met and all corrective measures will be completed.
Further details can also be found in the FDA Warning Letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. from 19 April, 2018.