9-11 April 2024
In a Warning Letter, the FDA describes the inadequate cleaning of product-contact surfaces and the associated risk of cross-contamination at an Egyptian pharmaceutical manufacturer.
The FDA inspection had already taken place at the end of 2022. After reviewing the responses to the 483 report issued, the Warning Letter now followed.
According to the FDA, the manufacturer failed to include all parts of the product-contacting equipment used for the manufacture of medicinal products in the cleaning validation protocols and procedures. The aforementioned documents do not include the transport containers used for transporting medicinal products and chemical product components during manufacturing, which creates a risk of cross-contamination. The manufacturer had opened a CAPA case after the inspection and conducted a cleaning validation of the transport containers. This was not sufficient for the FDA, as it did not contain a complete assessment of all possible uses of the transport container.
Furthermore, the FDA criticised the manufacturer's incoming goods inspection. For example, the manufacturer uses ethanol (as the active ingredient), which is not checked for identity at goods receipt and is not tested for methanol content. The glycerine used is not checked for the presence of diethylene glycol (DEG) or ethylene glycol (EG). These tests are regulated in the FDA's own guidelines, as deaths have already been caused by contaminated ethanol and glycerine.
For more details please see the original FDA Warning Letter on the FDA website.