17-19 November 2020
A Chinese company was placed on import alert by FDA because investigators observed significant deviations from current good manufacturing practice. This was summarised in a Warning Letter published in February. It seems that the company was actively hiding manufacturing activities and was not always telling the truth:
At the beginning of the inspection, the FDA investigator was told that the firm was currently not manufacturing crude heparin and was "only performing equipment testing". However during a walkthrough, a warehouse employee was leaving the warehouse with a fiber drum. The investigator wanted to check the drum and got the reply that the drum contained bags. But the drums contained two batches of crude heparin "manufactured just a few days before the FDA inspection". Even worse, the firm had to admit that they had no records for the two batches. Later in the investigation it became clear that the company manufactured several batches of crude heparin (batch numbers CU190601 to CU190730) over a period of two months but could only provide two complete batch records.
But that was not all. During the walkthrough the investigator found "numerous records on the floor, desks, and cabinets of the Quality Assurance (QA) Office", including batch production records. An employee said that these were not real records and that the "crude heparin batches specified in the records had not actually been manufactured", because they were generated for the purpose "to support an application for government funding". That was also not the truth and the company had to admit later that "all the records in the QA Office were in fact associated with genuine crude heparin batches".
FDA placed the firm on Import Alert 66-40 (Detention without physical Examination of Drugs from Firms which have not met Drug GMPs) and 55-03 (Detention without physical Examination of different Forms of Heparin and heparin-related Products).