North Columbus News

There were two companies in a city associated with Delaware County that received FDA citations as a result of two 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:

• You did not develop an FSVP.
• Procedures for management review have not been adequately established.
• Procedures for quality audits have not been adequately established.

The companies cited were involved in either Food and Cosmetics or Devices sectors.

Both 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Aunt Flow, CORP	Devices	05/08/2025	Management review - Lack of or inadequate procedures
Aunt Flow, CORP	Devices	05/08/2025	Quality audits - Lack of or inadequate procedures
Aunt Flow, CORP	Devices	05/08/2025	Training - Lack of or inadequate procedures
Aunt Flow, CORP	Devices	05/08/2025	Design control - no procedures
Aunt Flow, CORP	Devices	05/08/2025	Evaluation of suppliers, contractors, etc., requirements
Aunt Flow, CORP	Devices	05/08/2025	Lack of or inadequate procedures
Aunt Flow, CORP	Devices	05/08/2025	Lack of or inadequate complaint procedures
Jain Americas, Inc.	Food and Cosmetics	04/14/2025	Develop FSVP