15/16 February 2022
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
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.