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St. Louis Reporter

Tuesday, April 22, 2025

How many companies City of St. Louis received FDA citations in March?

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

There was one company in the City of St. Louis that received an FDA citation as a result of one inspection conducted in the city in March, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The only citation issued in the city was delivered as 'The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830'.

The company cited should take a voluntary action to correct its managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality.

Companies located within City of St. Louis and the citations they received in March
Company NameArea of BusinessInspection DateIssue Cited
Fundus Photo, LLCDevices03/26/2025Label to bear a unique device identifier

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