Himalaya Wellness USA, Ltd. in Sugar Land cited after FDA inspection finds 3 violations

Sean R. Keveney J.D., Chief Counsel of FDA
Sean R. Keveney J.D., Chief Counsel of FDA
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The Food and Drug Administration cited Himalaya Wellness USA, Ltd. in Sugar Land for three violations regarding foodborne biological hazards following an inspection conducted Jan. 30, according to details published on the FDA’s website.

Data posted by the FDA outlines the following citations given to the company:

  • ‘You did not establish written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food.’
  • ‘You did not determine and document which verification activity or activities are needed to provide adequate assurance that the foreign supplier is producing a dietary supplement in accordance with processes and procedures that provide the required level of public health protection.’
  • ‘You did not conduct and document or obtain documentation of one or more foreign supplier verification activities before importing a dietary supplement.’

The FDA conducts inspections of facilities nationwide to check whether facilities and products adhere to FDA laws and regulations established for public health. The agency releases inspection findings to the public.

As described on its official website, the FDA is responsible for overseeing the manufacturing and distribution of drugs, biological products, medical devices, and tobacco products to verify their safety and quality.

Information featured in this article was obtained from the U.S. Food and Drug Administration. Source data is available here.



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