SLO Reporter

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

This is a 50% increase over the number of companies cited in the previous year.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
• There is no written testing program designed to assess the stability characteristics of drug products.

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

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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
Airgas USA, LLC	Drugs	03/09/2023	Calibration/Inspection/Checking not done
Elemental Herbs, Inc.	Drugs	02/03/2023	Lack of quality control unit
Elemental Herbs, Inc.	Drugs	02/03/2023	Expiration date lacking
Elemental Herbs, Inc.	Drugs	02/03/2023	Written program not followed
H J Harkins Company, Inc.	Drugs	03/03/2023	Procedures not in writing, fully followed
H J Harkins Company, Inc.	Drugs	03/03/2023	Written calibration / inspection records not kept
H J Harkins Company, Inc.	Drugs	03/03/2023	Lack of written stability program
H J Harkins Company, Inc.	Drugs	03/03/2023	Review of representative number of batches