South Dayton News

There were 10 companies in cities associated with Montgomery County that received FDA citations as a result of 10 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 42.9% increase over the number of companies cited in the previous year.

Of the 33 citations issued, the most common citations were 'Your hazard analysis did not identify a hazard that required a preventive control' and 'Procedures for corrective and preventive action have not been adequately established'.

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, nine should take voluntary actions to correct their managing operations (90%). Additionally, one company had to take regulatory and/or administrative actions (10%).

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
APS Materials, Inc.	Devices	03/15/2023	Rationale documented for no investigation
BNG Miracle Pet, LLC	Veterinary	10/10/2023	Hazard Analysis
BNG Miracle Pet, LLC	Veterinary	10/10/2023	Preventive Controls
BNG Miracle Pet, LLC	Veterinary	10/10/2023	Adequacy of Corrective Actions Implemented
BNG Miracle Pet, LLC	Veterinary	10/10/2023	Validation of Process or Other Preventive Control
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Specifications - product received for packaging, labeling
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Reserve sample - twice the quantity
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Written procedure quality control operations material review
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Master manufacturing record - each batch
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Batch record - complete
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Written procedures - holding
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Product complaint - quality control review
Basic Drugs, Inc.	Food and Cosmetics	05/30/2023	Quality control - processes, specifications, written procedures
Cassanos, Inc.	Food and Cosmetics	08/24/2023	Personnel
Cassanos, Inc.	Food and Cosmetics	08/24/2023	Hazard analysis - Identification of hazard
Cassanos, Inc.	Food and Cosmetics	08/24/2023	Process preventive controls - Appropriate (Adequate)
Dorothy Lane Market, Inc.	Food and Cosmetics	09/22/2023	Hazard analysis - Identification of hazard
Johnson Medtech, LLC	Devices	11/27/2023	Production processes
Johnson Medtech, LLC	Devices	11/27/2023	Documentation
Johnson Medtech, LLC	Devices	11/27/2023	Acceptance status
Johnson Medtech, LLC	Devices	11/27/2023	Lack of or inadequate procedures
Malt Products Corporation	Food and Cosmetics	02/24/2023	Sanitation preventive controls - Implement
Milanos Bread, LLC	Food and Cosmetics	01/27/2023	Sanitary operations - Plant maintenance
Milanos Bread, LLC	Food and Cosmetics	01/27/2023	Sanitary operations - Plant sanitation
Milanos Bread, LLC	Food and Cosmetics	01/27/2023	Sanitation of food-contact surfaces - Frequency
Milanos Bread, LLC	Food and Cosmetics	01/27/2023	Equipment and utensils - Design and maintenance
Mirac, LLC	Devices	05/11/2023	Quality audits - auditor independence
Mirac, LLC	Devices	05/11/2023	Lack of or inadequate process validation
Mirac, LLC	Devices	05/11/2023	Nonconforming product, Lack of or inadequate procedures
Mirac, LLC	Devices	05/11/2023	Lack of or inadequate procedures
Mirac, LLC	Devices	05/11/2023	Lack of or inadequate complaint procedures
Steven D. Folkerth, M.D.	Drugs	01/13/2023	FD-1572, protocol compliance
Steven D. Folkerth, M.D.	Drugs	01/13/2023	Accountability records