NW Riverside News

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

This is a 40% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

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

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
Adonis, Inc.	Drugs	11/03/2023	Procedures not in writing, fully followed
Adonis, Inc.	Drugs	11/03/2023	Equipment Design, Size and Location
Adonis, Inc.	Drugs	11/03/2023	Cleaning / Sanitizing / Maintenance
Adonis, Inc.	Drugs	11/03/2023	Reports of Analysis (Components)
Adonis, Inc.	Drugs	11/03/2023	Absence of Written Procedures
Adonis, Inc.	Drugs	11/03/2023	Strict control not exercised over labeling issued
American Reproductive Centers	Biologics	12/06/2023	Responsible person to determine, document
American Reproductive Centers	Biologics	12/06/2023	Specimen collections not timely
T & J Processors, LLC	Food and Cosmetics	10/25/2023	No HACCP plan