4/5 February 2020
Prague, Czech Republic
One of the most severe incidents involving contaminated drugs occurred 1995 in Haiti, where 88 children died of diethylene glycol poisoning. They had taken a cough syrup which instead of the excipient glycerin contained DEG, which is usually used as an antifreeze agent. Despite the extensive media coverage of the scandal, drug products containing DEG kept turning up during the following years (in Argentina, Bangladesh, India, Nigeria) - another tragic case took place in Panama, where over 100 people lost their lives. In almost all cases, this could be traced back to a failure in the quality assurance/quality control of the companies that processed the excipient in their preparations:
In order to get a grip on this threatening situation and reduce the potential threat for consumers (in the USA), the FDA published their Guidance for Industry "Testing of Glycerin for Diethylene Glycol" in May 2007. This guideline contains recommendations on how to test the excipient glycerin for DEG contamination before its further processing in the manufacturing process of the medicinal product.
This guideline and the basic expectations of the FDA on the topic of glycerin do not appear to be familiar to the Irish company Europharma Concepts Limited. Half a year after the FDA inspectors visit, general management received an FDA warning letter, in which the critical finding regarding the poor quality control for glycerin as well as other failures concerning the control of incoming starting materials and the validation of manufacturing processes are described in detail. Here is a short summary:
The FDA does not issue a warning letter solely based on the deficiencies the inspectors discover at the site of a company; the company's response is decisive. Europharma's response was deemed inadequate by the FDA for the following reasons:
This resulted in the following additional demands, for which Europharma was given 15 working days:
Europharma has been placed on Import Alert by the FDA.