Louisville City Wire

There were 13 companies in a city associated with Jefferson 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 an 85.7% increase over the number of companies cited in the previous year.

Of the 40 citations issued, the most common citation was 'You did not maintain your plant in a clean and sanitary condition and in adequate repair'.

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 Devices sector.

Of the companies cited, 12 should take voluntary actions to correct their managing operations (92.3%). Additionally, one company had to take regulatory and/or administrative actions (7.7%).

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
Alani Nutrition	Food and Cosmetics	07/19/2023	Personnel - records - training
Alani Nutrition	Food and Cosmetics	07/19/2023	Written procedure quality control operations material review
Botanical Processing	Food and Cosmetics	09/29/2023	Specifications - component identity
Botanical Processing	Food and Cosmetics	09/29/2023	Specifications-component purity, strength, composition
Botanical Processing	Food and Cosmetics	09/29/2023	Specifications - contamination limits
Botanical Processing	Food and Cosmetics	09/29/2023	Specifications - contamination limits
Botanical Processing	Food and Cosmetics	09/29/2023	Specifications - identity, purity, strength, composition
Botanical Processing	Food and Cosmetics	09/29/2023	Written procedures - quality control operations
Botanical Processing	Food and Cosmetics	09/29/2023	Master manufacturing record - each batch
Botanical Processing	Food and Cosmetics	09/29/2023	Written procedures - laboratory operations
CS Health, LLC	Food and Cosmetics	02/23/2023	Written procedure quality control operations material review
DRE Medical Group, Inc.	Devices	05/19/2023	Lack of Written MDR Procedures
DRE Medical Group, Inc.	Devices	05/19/2023	Acceptable supplier records, inadequate records
DRE Medical Group, Inc.	Devices	05/19/2023	Nonconforming product, Lack of or inadequate procedures
DRE Medical Group, Inc.	Devices	05/19/2023	Documentation
DRE Medical Group, Inc.	Devices	05/19/2023	Complaints
DRE Medical Group, Inc.	Devices	05/19/2023	Lack of or inadequate complaint procedures
Desserts by Helen, Inc.	Food and Cosmetics	03/13/2023	Qualifications of individuals
Desserts by Helen, Inc.	Food and Cosmetics	03/13/2023	Personnel
Desserts by Helen, Inc.	Food and Cosmetics	03/13/2023	Plant construction and design
Desserts by Helen, Inc.	Food and Cosmetics	03/13/2023	Sanitary operations - Plant maintenance
Desserts by Helen, Inc.	Food and Cosmetics	03/13/2023	Sanitary operations - Plant sanitation
Desserts by Helen, Inc.	Food and Cosmetics	03/13/2023	Sanitary facilities and controls
Don A. Stevens, M.D.	Drugs	04/13/2023	FD-1572, protocol compliance
Don A. Stevens, M.D.	Drugs	04/13/2023	Case history records- inadequate or inadequate
Eurest Dining Services	Food and Cosmetics	02/08/2023	Grounds
Eurest Dining Services	Food and Cosmetics	02/08/2023	Sanitary operations - Plant maintenance
Eurest Dining Services	Food and Cosmetics	02/08/2023	Toxic chemicals - Identified, held, stored
Hilco, LLC	Food and Cosmetics	02/03/2023	Hazard analysis written
Hilco, LLC	Food and Cosmetics	02/03/2023	Document review entity's hazard analysis
Hilco, LLC	Food and Cosmetics	02/03/2023	Evaluation - performance, risk
Louisville Reproductive Center	Biologics	08/22/2023	Name and personal info on accompanying records
Med-Dyne, Inc.	Devices	01/30/2023	Lack of System for Event Evaluations
Rosa De Oro Bakery, LLC	Food and Cosmetics	08/23/2023	Personnel
Rosa De Oro Bakery, LLC	Food and Cosmetics	08/23/2023	Sanitary operations - Plant maintenance
Rosa De Oro Bakery, LLC	Food and Cosmetics	08/23/2023	Pest control
Shuckmans Fish Company & Smokery, Inc.	Food and Cosmetics	06/08/2023	HACCP plan implementation
Shuckmans Fish Company & Smokery, Inc.	Food and Cosmetics	06/08/2023	Signed and dated
Thorn BioScience, LLC	Veterinary	05/26/2023	Lab controls established, including changes
Thorn BioScience, LLC	Veterinary	05/26/2023	Review of representative number of batches