9/10 March 2021
This FDA Warning Letter to the Japanese manufacturer Sato Yakuhin Kogyo Co. Ltd of 6 January 2017 is based on an FDA inspection in June 2016.
Specifically, the authority criticized incomplete data in the HPLC and UV analysis.
In reviewing the audit trail of the HPLC system, the FDA inspector found that an analysis sequence for the determination of impurities was carried out again about 24 hours later, but that none of the 19 chromatograms of the first analysis were stored and were thus not available for review. The company had no reason why the original data were not kept and there was also no scientific justification for repeating this HPLC analysis.
The electronic data for the UV spectrophotometer were also not stored. This was used to determine the content uniformity and the identity test for capsules. The instrument used did not have an audit trail.
Sato Yakuhin had previously written to the FDA that the company's prior "Data Integrity" controls had been incomplete and that all electronic data would be kept in the future. This response was not appropriate from the FDA's point of view because the company had not carried out a retrospective review to assess whether the defective data had compromised the quality of the medicinal products. The company had also not shown how the changed laboratory work procedures were to ensure that data can not be removed, manipulated or deleted.
To get the details please see the FDA's Warning Letter to Sato Yakuhin Kogyo.