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South Franklin News

Tuesday, September 9, 2025

How many companies in cities across Franklin County received FDA citations in Q2?

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Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website

There were three companies in cities associated with Franklin County that received FDA citations as a result of three inspections conducted in the county over the second quarter of 2025, 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 quarter.

The citations in the county include:

  • Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in packaging and labeling of a drug product.
  • You did not develop an FSVP.
  • Procedures for management review have not been adequately established.

All of the companies cited were involved in either Drugs, Food and Cosmetics, or Devices sectors.

All of the companies cited should take voluntary actions to correct their 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 Franklin County Cities and the citations they received in Q2
Company NameArea of BusinessInspection DateIssue Cited
Aunt Flow, CORPDevices05/08/2025Management review - Lack of or inadequate procedures
Aunt Flow, CORPDevices05/08/2025Quality audits - Lack of or inadequate procedures
Aunt Flow, CORPDevices05/08/2025Training - Lack of or inadequate procedures
Aunt Flow, CORPDevices05/08/2025Design control - no procedures
Aunt Flow, CORPDevices05/08/2025Evaluation of suppliers, contractors, etc., requirements
Aunt Flow, CORPDevices05/08/2025Lack of or inadequate procedures
Aunt Flow, CORPDevices05/08/2025Lack of or inadequate complaint procedures
Integrated Commercialization Solutions, LLCDrugs05/15/2025Sampling/testing of labeling/packaging materials
Jain Americas, Inc.Food and Cosmetics04/14/2025Develop FSVP

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