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Thursday, September 19, 2024

FDA: 1 company in cities within Wayne County received 12 citations in April

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Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website

There was one company in a city associated with Wayne County that received FDA citations as a result of one inspection conducted in the county in April, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

  • Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
  • The plumbing in your physical plant was not adequate to avoid being a source of contamination to components, dietary supplements, water supplies, or any contact surface or creating an unsanitary condition.
  • The plumbing in your physical plant did not provide adequate floor drainage in areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.

The company cited was involved in the Food and Cosmetics sector.

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.

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, according to its website.

Companies located within Wayne County Cities and the citations they received in April
Company NameArea of BusinessInspection DateIssue Cited
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Personnel - hygienic practices
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Plumbing - source of contamination
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Plumbing - floor drainage
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Hand-washing facilities
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Physical plant - separate areas - cleaning, sanitizing
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Equipment - maintain - general
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Equipment - automated - calibrate, inspect
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Specifications - component identity
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Specifications-component purity, strength, composition
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Specifications - identity, purity, strength, composition
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Batch record - complete
Enrinity Supplements, Inc.Food and Cosmetics04/22/2024Batch record - results; monitoring

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