SE Oakland News

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Garden Fresh Gourmet, LLC	Food and Cosmetics	04/12/2023	Hazard analysis - Identification of hazard
Gemini Import Export, LLC	Food and Cosmetics	01/10/2023	Hazard analysis biological, chemical, physical
Gemini Import Export, LLC	Food and Cosmetics	01/10/2023	Supplier approval - document
Gemini Import Export, LLC	Food and Cosmetics	01/10/2023	Verification activity frequency
Kar Nut Products Company	Food and Cosmetics	12/21/2023	Allergen preventive controls - Implement
Kar Nut Products Company	Food and Cosmetics	12/21/2023	Sanitation preventive controls - Implement
Kar Nut Products Company	Food and Cosmetics	12/21/2023	Process preventive controls - Appropriate (Adequate)
LXR Biotech	Drugs	01/20/2023	Lack of quality control unit
LXR Biotech	Drugs	01/20/2023	Procedures not in writing, fully followed
LXR Biotech	Drugs	01/20/2023	Representative Samples
LXR Biotech	Drugs	01/20/2023	Absence of Written Procedures
LXR Biotech	Drugs	01/20/2023	Procedures are written, and followed
LXR Biotech	Drugs	01/20/2023	Scientifically sound laboratory controls
LXR Biotech	Drugs	01/20/2023	Prepared for each batch, include complete information
La Vie Import And Export	Food and Cosmetics	02/26/2023	Develop FSVP
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Develop FSVP
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Evaluation - performance, risk
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Supplier approval - document
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Approved supplier procedures - importer established
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Supplier verification - establish written procedures
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Verification activity assurance
Moghul Foods, LLC	Food and Cosmetics	05/30/2023	Verification activity before import, periodically
PAR Sterile Products, LLC	Drugs	04/14/2023	Procedures for sterile drug products