How many companies in cities across Marion County received FDA citations in 2024?

How many companies in cities across Marion County received FDA citations in 2024?
Mark Raza Principal Deputy Chief Counsel - FDA — Official Website
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There were 13 companies in a city associated with Marion County that received FDA citations as a result of 13 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 116.7% increase over the number of companies cited in the previous year.

Of the 33 citations issued, the most common citation was ‘Your written sanitation preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control’.

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 Biologics sector.

Of the companies cited, 12 should take voluntary actions to correct their managing operations (92.3%).

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.

According to its website, 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.

Companies Located Within Marion County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
ALOM Technologies Corporation Devices 10/17/2024 Lack of or inadequate procedures
Blair M. Brengle, M.D. Drugs 08/29/2024 Case history records- inadequate or inadequate
Blair M. Brengle, M.D. Drugs 08/29/2024 Safety Reports – Non-Serious Events
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 Hazard analysis
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 HACCP plan implementation
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 Food safety hazards
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 Verification procedures – none/frequency
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 Signed and dated
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 Sanitation monitoring
Chef for Hire, Inc. Food and Cosmetics 05/03/2024 Sanitation Records
Community Fertility Specialty Care Biologics 01/11/2024 Design of procedures to ensure compliance
Community Fertility Specialty Care Biologics 01/11/2024 Documentation–determination, by whom, date
Community Fertility Specialty Care Biologics 01/11/2024 Infection with communicable disease agents
Concentrics Research, LLC Drugs 11/26/2024 Record retention requirement
Cosmo’s Superior Foods Veterinary 08/19/2024 Personnel
Cosmo’s Superior Foods Veterinary 08/19/2024 Hazard Analysis
Cosmo’s Superior Foods Veterinary 08/19/2024 Validation of Process or Other Preventive Control
Hong Sar, LLC Food and Cosmetics 09/13/2024 Pest control
Krispy Kreme Doughnut Corporation Food and Cosmetics 03/07/2024 Sanitation preventive controls – Implement
Krispy Kreme Doughnut Corporation Food and Cosmetics 03/07/2024 Sanitation preventive controls – Appropriate (Adequate)
Mondelez Global, LLC Food and Cosmetics 01/11/2024 Sanitation preventive controls – Appropriate (Adequate)
Ossium Health, Inc. Biologics 05/30/2024 Specified requirements for in-process controls
Ossium Health, Inc. Biologics 05/30/2024 Records maintained concurrently
Pasta-Bilities, Inc. Food and Cosmetics 06/24/2024 Process control – Foreign objects
Versiti Indiana, Inc. Biologics 09/30/2024 Establish, maintain and follow manufacturing SOPs
Versiti Indiana, Inc. Biologics 09/30/2024 Concurrent documentation
Versiti Indiana, Inc. Biologics 09/30/2024 Person performing, test results, interpretation
Versiti Indiana, Inc. Biologics 09/30/2024 Cleaned, sanitized per established schedules
Versiti Indiana, Inc. Biologics 09/30/2024 Procedures and release criteria
Versiti Indiana, Inc. Biologics 09/30/2024 Records incomplete
Vesta Pharmaceuticals, Inc. Food and Cosmetics 02/09/2024 Quality control operations – calibration records
Vesta Pharmaceuticals, Inc. Food and Cosmetics 02/09/2024 Batch record – quality control review; production
Vesta Pharmaceuticals, Inc. Food and Cosmetics 02/09/2024 Hold – mix-up, contamination, deterioration


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