Capitol News

There was one company in a city associated with Eaton County that received FDA citations as a result of one inspection conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• You did not implement quality control operations to ensure the quality of the dietary supplement.
• You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
• You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.

The company cited was involved in the Food and Cosmetics sector.

The company cited had to take regulatory and/or administrative actions.

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
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Quality control - quality, dietary supplement
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Specifications - contamination limits
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Specifications - identity, purity, strength, composition
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Component - verify identity, dietary ingredient
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Documentation - qualify supplier
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Components - quarantine
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Master manufacturing record - dietary ingredients
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Packaging description, representative label
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Instructions; specifications; quality
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Master manufacturing record - specific actions; quality
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - date, time; maintenance
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - component; identity, weight
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - results; monitoring
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - initials; verifying weight
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - initials; component
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - initials; verifying component
Spartan Enterprises, Inc.	Food and Cosmetics	10/17/2023	Batch record - quality control review; production