East SLC News

There were 15 companies in cities associated with Salt Lake County that received FDA citations as a result of 15 inspections conducted in the county throughout 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 year.

Of the 54 citations issued, the most common citations were 'Your batch production record did not include complete information relating to the production and control of each batch' and 'Acceptance or rejection of incoming product was not documented'.

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 Biologics 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
American National Red Cross, Lewis and Clark Region	Biologics	03/31/2023	Concurrent documentation
B & D Dental, Corp.	Devices	09/05/2023	Training records
B & D Dental, Corp.	Devices	09/05/2023	Design history file
B & D Dental, Corp.	Devices	09/05/2023	Procedures not adequately established or maintained
B & D Dental, Corp.	Devices	09/05/2023	Documented evaluation
B & D Dental, Corp.	Devices	09/05/2023	Environmental control Lack of or inadequate procedures
B & D Dental, Corp.	Devices	09/05/2023	Equipment control activity documentation
B & D Dental, Corp.	Devices	09/05/2023	Lack of or inadequate process validation
B & D Dental, Corp.	Devices	09/05/2023	Incoming acceptance records, documentation
B & D Dental, Corp.	Devices	09/05/2023	Nonconforming product, Lack of or inadequate procedures
B & D Dental, Corp.	Devices	09/05/2023	Product rework documentation, DHR {see also 820.184}
B & D Dental, Corp.	Devices	09/05/2023	Documentation
B & D Dental, Corp.	Devices	09/05/2023	Lack of or inadequate procedures for storage.
B & D Dental, Corp.	Devices	09/05/2023	DMR - not or inadequately maintained
B & D Dental, Corp.	Devices	09/05/2023	Lack of or inadequate DHR procedures
B & D Dental, Corp.	Devices	09/05/2023	Complaints
CellSure, L3C	Biologics	12/08/2023	Approve or reject procedures or specs
CellSure, L3C	Biologics	12/08/2023	Written warehousing procedures established/followed
CellSure, L3C	Biologics	12/08/2023	Written distribution procedure
CellSure, L3C	Biologics	12/08/2023	Lack of written stability program
CellSure, L3C	Biologics	12/08/2023	Risk factors, clinical evidence
CellSure, L3C	Biologics	12/08/2023	Eligibility not required--warning labels
FIOR Bioscience, LLC	Biologics	01/06/2023	Investigations of discrepancies, failures
John F. Foley, M.D.	Drugs	04/21/2023	FD-1572, protocol compliance
Matia Robotics US, Inc.	Devices	05/24/2023	Management review - defined interval, sufficient frequency
Matia Robotics US, Inc.	Devices	05/24/2023	Incoming acceptance records, documentation
Matia Robotics US, Inc.	Devices	05/24/2023	Investigation of device failures
Nelson Laboratories, LLC	Drugs	06/02/2023	Test methods
Nicola Longo, Ph. D., M.D.	Drugs	03/10/2023	FD-1572, protocol compliance
Nicola Longo, Ph. D., M.D.	Drugs	03/10/2023	Informed consent
Nicola Longo, Ph. D., M.D.	Drugs	03/10/2023	Case history records- inadequate or inadequate
Scientific Health Products, LLC	Food and Cosmetics	07/12/2023	Written procedures - quality control operations
Scientific Health Products, LLC	Food and Cosmetics	07/12/2023	Quality control operations - packaging, visual examinations
Scientific Health Products, LLC	Food and Cosmetics	07/12/2023	Master manufacturing record - each batch
Scientific Health Products, LLC	Food and Cosmetics	07/12/2023	Batch record - complete
Scientific Health Products, LLC	Food and Cosmetics	07/12/2023	Records - returned dietary supplement: written procedures
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Physical plant - clean and sanitary
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Specifications - contamination limits
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Specifications - identity, purity, strength, composition
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Documentation - qualify supplier
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Quality control - components, approve, release
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Master manufacturing record - unique formulation
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Batch record - complete
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Written procedures - holding
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Hold - mix-up, contamination, deterioration
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Quality control - processes, specifications, written procedures
Silver Shadow Ventures	Food and Cosmetics	08/03/2023	Quality control operations - master manufacturing record, modifications
Tres Enterprises, Inc.	Food and Cosmetics	01/10/2023	Develop FSVP
TruVision Health, LLC	Food and Cosmetics	04/17/2023	Quality control - reject; specification not met
TruVision Health, LLC	Food and Cosmetics	04/17/2023	Records - ret'nd dietary supplement: material review, dispos
TruVision Health, LLC	Food and Cosmetics	04/17/2023	Written procedures - product complaint
Utah Cord Bank, LLC	Biologics	01/06/2023	Contamination, mix ups, improper release
Wasatch Product Development, LLC	Food and Cosmetics	01/27/2023	Process adherence
Western Nut Company, Inc.	Food and Cosmetics	09/11/2023	Preventive controls - Implement (Limited Scope only)