SW Riverside News

There were 13 companies in cities associated with Riverside County that received FDA citations as a result of 13 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 13.3% decrease from the number of companies cited in the previous year.

Of the 29 citations issued, the most common citation was 'You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Veterinary 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
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
Alibaba Mediterranean Grill	Food and Cosmetics	06/30/2023	Develop FSVP
American Reproductive Centers	Biologics	12/06/2023	Responsible person to determine, document
American Reproductive Centers	Biologics	12/06/2023	Specimen collections not timely
Amzey, Inc.	Veterinary	08/01/2023	Evaluation - performance, risk
Amzey, Inc.	Veterinary	08/01/2023	Verification activity before import, periodically
Calmich Produce, Corp.	Food and Cosmetics	07/18/2023	Evaluation - performance, risk
Fronteras Food Group, LLC	Food and Cosmetics	05/10/2023	Develop FSVP
Husdow Global, Inc.	Food and Cosmetics	07/12/2023	Evaluation - performance, risk
Husdow Global, Inc.	Food and Cosmetics	07/12/2023	Approved supplier procedures - importer established
Life is Life, LLC	Food and Cosmetics	04/24/2023	Hazard analysis - Identification of hazard
OCPP, LLC	Veterinary	04/06/2023	Validation of Process or Other Preventive Control
Oostdam Dairy	Veterinary	07/18/2023	ELDU - producer causes Illegal drug residue
Oostdam Dairy	Veterinary	07/18/2023	Record keeping
Oostdam Dairy	Veterinary	07/18/2023	Records review prior to shipment for slaughter
Pensar Medical, LLC	Devices	02/16/2023	Design history file
Pensar Medical, LLC	Devices	02/16/2023	Acceptable supplier records, inadequate records
Pensar Medical, LLC	Devices	02/16/2023	Equipment control activity documentation
Pensar Medical, LLC	Devices	02/16/2023	Process changes - review, evaluation and revalidation
Pensar Medical, LLC	Devices	02/16/2023	Nonconforming product control
Pensar Medical, LLC	Devices	02/16/2023	Documentation
T & J Processors, LLC	Food and Cosmetics	10/25/2023	No HACCP plan
The Flavor Factory, Inc.	Food and Cosmetics	07/12/2023	Personnel
The Flavor Factory, Inc.	Food and Cosmetics	07/12/2023	Sanitary operations - Plant sanitation