FDA Warns Canadian Drugmaker for Refusing Photography During Inspection
The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated.
The agency also flagged inconsistencies in how the homeopathic drugmaker mixed ingredients for its products, including some containing belladonna.
In a warning letter to Homeolab USA, the FDA said the company used “an inherently variable process” to blend powders that are sent to a contract manufacturer, Raritan, for production.
Homeolab also failed to test the ingredients in the blends for purity, strength and quality, and did not test the blends to make sure they were uniform and homogenous, the agency said.