FDA issues 6 citations to LUTIMI NR, Corp. in Miramar following March 13 inspection

Grace Graham, Deputy Commissioner for Policy, Legislation, and International Affairs of FDA
Grace Graham, Deputy Commissioner for Policy, Legislation, and International Affairs of FDA
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During a March 13 inspection, LUTIMI NR, Corp. in Miramar was cited for six violations by the Food and Drug Administration (FDA), according to information available on the FDA’s website.

FDA inspectors reviewed the following categories:

  • Food Composition, Standards, Labeling and Econ
  • Foodborne Biological Hazards

Based on the FDA’s website, the company received citations in these areas:

  • ‘You allowed pests in your physical plant.’
  • ‘You did not establish written procedures for cleaning the physical plant and pest control.’
  • ‘You did not establish written procedures for quality control operations.’
  • ‘You did not establish written procedures for holding and distributing operations.’
  • ‘You did not establish written procedures for when a returned dietary supplement is received, when a returned dietary supplement must be destroyed, or otherwise suitably disposed and when a returned dietary supplement may be salvaged.’
  • ‘You did not establish written procedures for the requirements to review and investigate a product complaint.’

The FDA conducts routine inspections of facilities nationwide to ensure workplaces and their products adhere to FDA-governed laws. Results from these inspections are made publicly available.

The FDA describes itself as the federal agency overseeing safety and quality in the manufacture and distribution of drugs, biological products, medical devices, and tobacco products for humans and animals.

Information for this article was sourced from the U.S. Food and Drug Administration. Access the source data here.



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