FDA inspects Alfa Vitamins Laboratories in Miami, issues 5 citations on April 17

Sara Brenner, Principal Deputy Commissioner at FDA
Sara Brenner, Principal Deputy Commissioner at FDA
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The Food and Drug Administration (FDA) conducted an inspection at Alfa Vitamins Laboratories, Inc. in Miami on April 17, resulting in five citations, according to information on the FDA’s website.

The inspection reviewed the following areas:

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

As noted on the FDA website, the company was cited for the following reasons:

  • ‘You did not follow written procedures for fulfilling the requirements for maintaining, cleaning, and sanitizing, equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.’
  • ‘You did not establish product specifications for strength.’
  • ‘Your quality control operations did not include determining whether each finished batch conforms to established product specifications.’
  • ‘You did not establish written procedures for laboratory operations.’
  • ‘You did not make and keep records for your laboratory operations.’

The FDA regularly inspects facilities nationwide to evaluate whether workplaces and products adhere to FDA-regulated laws and guidelines aiming to safeguard public health. Inspection outcomes are published for public viewing.

According to its website, the FDA is the federal agency responsible for regulating the safety and quality of human and animal drugs, biological products, medical devices, and tobacco products.

Information in this article comes from the U.S. Food and Drug Administration. Original source data is available here.



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