Hamilton Reporter

There were four companies in a city associated with Hamilton County that received FDA citations as a result of four inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% decrease from the number of companies cited in the previous year.

Of the nine citations issued, the most common citation was 'The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed'.

Most of the companies cited were involved in the Drugs sector.

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.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
AKI, Inc.	Drugs	07/20/2023	Sanitation--buildings not clean, free of infestation
AKI, Inc.	Drugs	07/20/2023	Cleaning / Sanitizing / Maintenance
AKI, Inc.	Drugs	07/20/2023	Packaging line inspection after use
AKI, Inc.	Drugs	07/20/2023	Written records kept in individual logs
Fertility Center, LLC	Biologics	12/07/2023	Personal information included in I.D. code
Fertility Center, LLC	Biologics	12/07/2023	Name and personal info on accompanying records
RWM Technologies, LLC	Drugs	01/13/2023	Procedures not in writing, fully followed
RWM Technologies, LLC	Veterinary	01/13/2023	Procedures not in writing, fully followed
SRI Healthcare, LLC	Devices	01/12/2023	Process control procedures, Lack of or inadequate procedures