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Dayton Reporter

Wednesday, November 6, 2024

How many companies in cities across Montgomery County received FDA citations in 2023?

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Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website

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.

Companies Located Within Montgomery County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
APS Materials, Inc.Devices03/15/2023Rationale documented for no investigation
BNG Miracle Pet, LLCVeterinary10/10/2023Hazard Analysis
BNG Miracle Pet, LLCVeterinary10/10/2023Preventive Controls
BNG Miracle Pet, LLCVeterinary10/10/2023Adequacy of Corrective Actions Implemented
BNG Miracle Pet, LLCVeterinary10/10/2023Validation of Process or Other Preventive Control
Basic Drugs, Inc.Food and Cosmetics05/30/2023Specifications - product received for packaging, labeling
Basic Drugs, Inc.Food and Cosmetics05/30/2023Reserve sample - twice the quantity
Basic Drugs, Inc.Food and Cosmetics05/30/2023Written procedure quality control operations material review
Basic Drugs, Inc.Food and Cosmetics05/30/2023Master manufacturing record - each batch
Basic Drugs, Inc.Food and Cosmetics05/30/2023Batch record - complete
Basic Drugs, Inc.Food and Cosmetics05/30/2023Written procedures - holding
Basic Drugs, Inc.Food and Cosmetics05/30/2023Product complaint - quality control review
Basic Drugs, Inc.Food and Cosmetics05/30/2023Quality control - processes, specifications, written procedures
Cassanos, Inc.Food and Cosmetics08/24/2023Personnel
Cassanos, Inc.Food and Cosmetics08/24/2023Hazard analysis - Identification of hazard
Cassanos, Inc.Food and Cosmetics08/24/2023Process preventive controls - Appropriate (Adequate)
Dorothy Lane Market, Inc.Food and Cosmetics09/22/2023Hazard analysis - Identification of hazard
Johnson Medtech, LLCDevices11/27/2023Production processes
Johnson Medtech, LLCDevices11/27/2023Documentation
Johnson Medtech, LLCDevices11/27/2023Acceptance status
Johnson Medtech, LLCDevices11/27/2023Lack of or inadequate procedures
Malt Products CorporationFood and Cosmetics02/24/2023Sanitation preventive controls - Implement
Milanos Bread, LLCFood and Cosmetics01/27/2023Sanitary operations - Plant maintenance
Milanos Bread, LLCFood and Cosmetics01/27/2023Sanitary operations - Plant sanitation
Milanos Bread, LLCFood and Cosmetics01/27/2023Sanitation of food-contact surfaces - Frequency
Milanos Bread, LLCFood and Cosmetics01/27/2023Equipment and utensils - Design and maintenance
Mirac, LLCDevices05/11/2023Quality audits - auditor independence
Mirac, LLCDevices05/11/2023Lack of or inadequate process validation
Mirac, LLCDevices05/11/2023Nonconforming product, Lack of or inadequate procedures
Mirac, LLCDevices05/11/2023Lack of or inadequate procedures
Mirac, LLCDevices05/11/2023Lack of or inadequate complaint procedures
Steven D. Folkerth, M.D.Drugs01/13/2023FD-1572, protocol compliance
Steven D. Folkerth, M.D.Drugs01/13/2023Accountability records

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