Five new Warning Letters - Four Batch Record Review Citations

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7/8 May 2024

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The U.S. Food and Drug Administration FDA issued five new Warning Letters. In four of them, Batch Record processes were criticised.

Data integrity and governance is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots of these issues: document and batch record design and review (BRR). In the recent Warning Letters of the FDA these findings are cited more often now.

The Company Wuhan Chinese Moxibustion Technology for example was criticised for their product-specific master production and control records. These documents were lacking proper instructions like for "speed, time, and the order of component addition". After production the quality control unit "did not adequately review completed production records prior to drug product release". The batch records FDA has reviewed during the inspection showed "no test results" for the active ingredient which was used.

The quality control unit of the Chinese Company Yicheng Chemical Corporation seems to have similar problems. They also failed to review batch production records prior to the distribution of their active ingredients. Furthermore the company doesn't have repackaging batch records and the respective written procedures to describe how such a review should be done.

The Austrian company Schrofner Cosmetics "failed to establish and follow adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch". Even worse, they released finished products "without testing for the identity and strength of the active ingredient."

Batch record review is also rather difficult for the Chinese company Shanwei Honghui Daily Appliance. The reason is obvious: they "failed to prepare batch production and control records with complete information relating to the production and control". At least they were honest and told the inspector that "there was not a batch record for each batch".