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Inadequate batch records lead to USFDA warning letter

Updated: 27 March 2019

Recently, USFDA has issued a warning letter to a company based in Spain indicating the insufficient control records and batch production records.

Some of the incomplete documents illustrated by USFDA are missing information such as approval date and test results, use of correction liquid, no evidence stating a second individual has reviewed the documents, crossed-out or over written entries with "no signature, date, or explanation".

The firm was also unable to share the adequate stability testing program to USFDA. All these points represents that the quality system of the firm are inadequate leading them to receive import alert.