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Wednesday, November 20, 2024

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

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

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

This is a 12.5% decrease from the number of companies cited in the previous year.

Of the 23 citations issued, the most common citations were 'You did not develop an FSVP' and 'You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food'.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).

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.

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 Oakland County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
Garden Fresh Gourmet, LLCFood and Cosmetics04/12/2023Hazard analysis - Identification of hazard
Gemini Import Export, LLCFood and Cosmetics01/10/2023Hazard analysis biological, chemical, physical
Gemini Import Export, LLCFood and Cosmetics01/10/2023Supplier approval - document
Gemini Import Export, LLCFood and Cosmetics01/10/2023Verification activity frequency
Kar Nut Products CompanyFood and Cosmetics12/21/2023Allergen preventive controls - Implement
Kar Nut Products CompanyFood and Cosmetics12/21/2023Sanitation preventive controls - Implement
Kar Nut Products CompanyFood and Cosmetics12/21/2023Process preventive controls - Appropriate (Adequate)
LXR BiotechDrugs01/20/2023Lack of quality control unit
LXR BiotechDrugs01/20/2023Procedures not in writing, fully followed
LXR BiotechDrugs01/20/2023Representative Samples
LXR BiotechDrugs01/20/2023Absence of Written Procedures
LXR BiotechDrugs01/20/2023Procedures are written, and followed
LXR BiotechDrugs01/20/2023Scientifically sound laboratory controls
LXR BiotechDrugs01/20/2023Prepared for each batch, include complete information
La Vie Import And ExportFood and Cosmetics02/26/2023Develop FSVP
Moghul Foods, LLCFood and Cosmetics05/30/2023Develop FSVP
Moghul Foods, LLCFood and Cosmetics05/30/2023Evaluation - performance, risk
Moghul Foods, LLCFood and Cosmetics05/30/2023Supplier approval - document
Moghul Foods, LLCFood and Cosmetics05/30/2023Approved supplier procedures - importer established
Moghul Foods, LLCFood and Cosmetics05/30/2023Supplier verification - establish written procedures
Moghul Foods, LLCFood and Cosmetics05/30/2023Verification activity assurance
Moghul Foods, LLCFood and Cosmetics05/30/2023Verification activity before import, periodically
PAR Sterile Products, LLCDrugs04/14/2023Procedures for sterile drug products

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