US Manufacturer of homeopathic Medicines and nutritional Supplements receives FDA Warning Letter

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:

  • The buildings used for manufacturing, processing and packaging were not in a clean and hygienic condition
  • There was a lack of appropriate laboratory controls to ensure the identity, quality and purity of medicinal products, i.e. specifications, standards
  • Sampling plans and defined testing procedures were missing or not defined
  • Written production and process control procedures were missing or not approved by Quality Control.

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.  

  • Elimination of all deficiencies in cleaning procedures and current procedures
  • Detailed information on how to prevent visible residues from remaining on all surfaces, e.g. walls, floors and preparation surfaces.

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:

  • Products with higher toxicities;
  • Products with higher concentrations of active ingredients;
  • Products with lower solubility in their cleaning solvents;
  • Products with properties that make them difficult to clean;

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.

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