East SBV Times

There were 21 companies in cities associated with San Bernardino County that received FDA citations as a result of 22 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 10.5% increase over the number of companies cited in the previous year.

Of the 59 citations issued, the most common citation was 'You did not develop an FSVP'.

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 Drugs sector.

Of the companies cited, 20 should take voluntary actions to correct their managing operations (95.2%). Additionally, two companies had to take regulatory and/or administrative actions (9.5%).

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
Andrew, LLC	Food and Cosmetics	05/01/2023	Develop FSVP
DPI Specialty Foods West, Inc.	Food and Cosmetics	10/17/2023	Develop FSVP
Del Rio Produce, Inc.	Food and Cosmetics	06/27/2023	Develop FSVP
Fashion City International, Corp.	Food and Cosmetics	08/29/2023	Develop FSVP
Fashion City International, Corp.	Food and Cosmetics	08/29/2023	Approved supplier procedures - importer established
LA Surtidora Cash & Carry, Inc.	Food and Cosmetics	09/22/2023	Develop FSVP
Loma Linda University Center for Fertility and IVF	Biologics	03/02/2023	Testing, screening, donor eligibility procedures
Loma Linda University Center for Fertility and IVF	Biologics	03/02/2023	Determination based on screening and testing
Loma Linda University Center for Fertility and IVF	Biologics	03/02/2023	Name and personal info on accompanying records
Loma Linda University Center for Fertility and IVF	Biologics	03/02/2023	Risk factors, clinical evidence
Lucky Mart, Inc.	Food and Cosmetics	07/10/2023	Specifications met - verify; finished batch
Lucky Mart, Inc.	Food and Cosmetics	07/10/2023	Quality control - ensure quality; package, labeled, master record
Maple Lane Bakery, Inc.	Food and Cosmetics	10/27/2023	Personnel
Maple Lane Bakery, Inc.	Food and Cosmetics	10/27/2023	Plant construction and design
Minsley, Inc.	Food and Cosmetics	08/25/2023	Process filing
Myojo USA, Inc.	Food and Cosmetics	11/01/2023	Process filing
Myojo USA, Inc.	Food and Cosmetics	11/01/2023	Code - required elements
Old Town Baking Company, Inc.	Food and Cosmetics	05/04/2023	Sanitary operations - Plant maintenance
Old Town Baking Company, Inc.	Food and Cosmetics	05/04/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Old Town Baking Company, Inc.	Food and Cosmetics	05/04/2023	Raw materials - Allergen identification
Old Town Baking Company, Inc.	Food and Cosmetics	05/04/2023	Manufacturing, processing, packing, holding - Controls
Old Town Baking Company, Inc.	Food and Cosmetics	05/04/2023	Modified requirement: Temperature control - Implement
Pharma-Chem Enterprise, Inc.	Food and Cosmetics	08/25/2023	Identification - entry
Pharma-Chem Enterprise, Inc.	Food and Cosmetics	08/25/2023	No CGMPs - supplier approval, performance, risk
Rise Baking Company	Food and Cosmetics	06/07/2023	Equipment and utensils - Design and maintenance
Rise Baking Company	Veterinary	06/07/2023	Equipment and utensils - Design and maintenance
San Bernardino International Airport	Food and Cosmetics	10/25/2023	Prevention of the spread of communicable diseases
San Bernardino International Airport	Food and Cosmetics	10/25/2023	Prevention of contamination
Sky Chefs, Inc.	Food and Cosmetics	10/27/2023	Manufacturing, processing, packing, holding - Controls
Soup Bases Loaded, Inc.	Food and Cosmetics	04/14/2023	Process filing
Specialty Company Pack	Food and Cosmetics	03/31/2023	Process filing
Swabplus, L. P.	Drugs	08/01/2023	Procedures not in writing, fully followed
Swabplus, L. P.	Drugs	08/01/2023	Buildings not maintained in good state of repair
Swabplus, L. P.	Drugs	08/01/2023	Equipment Design, Size and Location
Swabplus, L. P.	Drugs	08/01/2023	Computer control of master formula records
Swabplus, L. P.	Drugs	08/01/2023	Component written specification
Swabplus, L. P.	Drugs	08/01/2023	SOPs not followed / documented
Swabplus, L. P.	Drugs	08/01/2023	Procedures for non-sterile drug products
Swabplus, L. P.	Drugs	08/01/2023	Expiration date lacking
Swabplus, L. P.	Drugs	08/01/2023	Deviations from laboratory control requirements
Swabplus, L. P.	Drugs	08/01/2023	Scientifically sound laboratory controls
Table de France, Inc.	Food and Cosmetics	10/20/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Table de France, Inc.	Food and Cosmetics	10/20/2023	Manufacturing, processing, packing, holding - Controls
Table de France, Inc.	Food and Cosmetics	10/20/2023	Process control - Foreign objects
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Procedures not in writing, fully followed
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Mfg / Processing Operations Area
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Written procedures not established/followed
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Computer control of master formula records
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Absence of Written Procedures
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Following/documenting laboratory controls
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Scientifically sound laboratory controls
Universal Packaging Systems, Inc.	Drugs	11/17/2023	Extent of discrepancy, failure investigations
Universal Packaging Systems, Inc.	Drugs	03/17/2023	Sanitation--buildings not clean, free of infestation
Universal Packaging Systems, Inc.	Drugs	03/17/2023	Equipment Design, Size and Location
Universal Packaging Systems, Inc.	Drugs	03/17/2023	Calibration/Inspection/Checking not done
Universal Packaging Systems, Inc.	Drugs	03/17/2023	Component identification test
Universal Packaging Systems, Inc.	Drugs	03/17/2023	Absence of Written Procedures
Wholesome International, Inc.	Food and Cosmetics	06/30/2023	Toxic chemicals - Identified, held, stored
Wholesome International, Inc.	Food and Cosmetics	06/30/2023	Modified requirement: Temperature control - Records