FDA Warning Letter for inadequate Batch Record Review

Recommendation

7/8 May 2024

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The U.S. Food and Drug Administration (FDA) recently posted a Warning Letter for a Chinese API manufacturer criticising the quality unit for not exercising its responsibility adequately.

For example, batch production records

• "contained blank or partially completed manufacturing data"
• "lacked dates and signatures for verification"
• "contained sticky notes from the quality assurance department directing operators to enter manufacturing data"
• were not approved by the quality unit

Also other documents like, for example, cleaning records and equipment use logs were found "without dates and signatures for verification, or with pages or spaces intentionally left blank for documentation at a later time".

As a conclusion, FDA stated that these "significant inspection findings indicate that your quality unit is not fully exercising its authority and/or responsibilities". And FDA placed the company on Import Alert.

Source: FDA Warning Letter to Qinhuangdao Zizhu Pharmaceutical.