28/29 April 2020
Prague, Czech Republic
In a current Warning Letter, the FDA describes the process validation requirements imposed on a contract manufacturer of homeopathic medicinal products.
In the course of an FDA inspection, the investigator discovered that the content of a homeopathic drug did not correspond to the declaration. There was no process validation. In order for the company to be allowed to export to the USA again, the FDA expects, among other things, the following:
Other points of criticism by the FDA were the inadequate testing of starting materials (21 CFR 211.84) and the inadequate functioning of the Quality Control Unit (21 CFR 211.22). Referring to 21 CFR 211.34, the FDA recommends engaging a GMP consultant. Finally, the FDA explains to the contractor that contractors are seen as "extended arm" of the external manufacturer and that they therefore remain responsible for the product.
You can find the Warning Letter on the FDA website.