NW Atlanta News

There was one company in a city associated with Bartow County that received FDA citations as a result of one inspection conducted in the county throughout 2023, 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 year.

The citations in the county include:

• There is no quality control unit.
• Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
• Approved components, drug product containers and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods with subsequent approval or rejection by the quality control unit.

The company cited was involved in the Drugs sector.

The company cited had to take regulatory and/or administrative actions.

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
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Lack of quality control unit
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Reports of Analysis (Components)
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Retest of approved components/containers/closures
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Control procedures to monitor and validate performance
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Expiration date lacking
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Scientifically sound laboratory controls
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Testing and release for distribution
Sani-Care Salon Products, Inc.	Drugs	11/03/2023	Batch production and Batch Control Record Requirements