Heparin is once again in the FDA spotlight.
In a recent post by Zachary Brennan, another Chinese manufacturer, Yibin Lihao, was placed on import alert following an FDA inspection.
The warning letter for Yibin Liaho is available at the following link.
As noted in the warning letter:
During a pre-inspectional call on July 10, 2019, your firm stated to FDA that you had not manufactured any materials for months. At the start of the FDA inspection on July 31, 2019, your firm stated to the investigator that you were not manufacturing crude heparin and were only per forming equipment testing.
During a walkthrough of your warehouse, the investigator observed a warehouse employee leaving the warehouse with a fiber drum and inquired about the contents of the drum. Your firm stated that the drum contained [redacted] bags. However. inspection of the drum revealed two batches of crude heparin manufactured just a few days before the FDA inspection (CU190726, [redacted], manufacturing date July 26, 2019, and CU 190727, [redacted], manufacturing date July 27, 2019). When asked about manufacturing and testing records pertaining to these two crude heparin batches, your firm told us that you do not have records for the two crude heparin batches.
This is not the first time that Heparin has been in the news. You may recall that in 2007/2008 Heparin contamination resulted in the deaths of 149 Americans. Traditional chemistry methods did not identify the contaminate, and it was only after new test methods were developed that the contaminate, oversulfated chondroitin sulfate, a heparin-like product derived from animal cartilage was identified. It was postulated by FDA in the Heparin Guidance for Industry document that this contaminate was intentionally added to the product as a form of economically motivated adulteration. The contaminate was intentionally added to reduce the cost of production.