18-20 November 2020
In December, the FDA issued a warning letter to OHM Pharma, a manufacturer of homeopathic medicines and dietary supplements. The warning letter included several listed deviations or deficiencies,, e.g:
For example, the premises showed powdery white residues on the surfaces, although these were declared clean and tidy and were not in operation at the time of inspection. In addition, there was no clear separation between equipment used for dietary supplements and pharmaceuticals, although some of the processed substances had significant toxic potential and others were intended for infants and children. This increased the risk of cross-contamination.
Accordingly, the FDA calls for a comprehensive review, e.g.
In addition, the authority expects a valid cleaning programme, which will be drawn up under identification and consideration of worst-case scenarios and will place a special focus on substances and products with hazardous properties, e.g:
In addition, swabbing points for areas that are most difficult to clean and maximum holding times before cleaning should be defined and taken into account.
Learn more about the details and requirements of the FDA in the Warning Letter to OHM Pharma dated December 19, 2019.