North Michigan News

There were two companies in a city associated with Leelanau County that received FDA citations as a result of two inspections conducted in the county throughout 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 year.

Of the 45 citations issued, the most common citations include:

• You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods.
• You did not establish an identity specification for each component.
• You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.

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

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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
Pure Simple Products	Food and Cosmetics	08/16/2023	Registration
Pure Simple Products	Food and Cosmetics	08/16/2023	Procedures - calibrating instruments
Pure Simple Products	Food and Cosmetics	08/16/2023	Specifications - component identity
Pure Simple Products	Food and Cosmetics	08/16/2023	Specifications - labels, packaging
Pure Simple Products	Food and Cosmetics	08/16/2023	Specifications - contamination limits
Pure Simple Products	Food and Cosmetics	08/16/2023	Specifications - identity, purity, strength, composition
Pure Simple Products	Food and Cosmetics	08/16/2023	Written procedures - quality control operations
Pure Simple Products	Food and Cosmetics	08/16/2023	Written procedures - components
Pure Simple Products	Food and Cosmetics	08/16/2023	Master manufacturing record - unique formulation
Pure Simple Products	Food and Cosmetics	08/16/2023	Master manufacturing record-specifications; packaged, label
Pure Simple Products	Food and Cosmetics	08/16/2023	Master manufacturing record theoretical and expected yield
Pure Simple Products	Food and Cosmetics	08/16/2023	Packaging description, representative label
Pure Simple Products	Food and Cosmetics	08/16/2023	Master manufacturing record - sampling, tests, examinations
Pure Simple Products	Food and Cosmetics	08/16/2023	Master manufacturing record - specific actions; quality
Pure Simple Products	Food and Cosmetics	08/16/2023	Corrective action plans
Pure Simple Products	Food and Cosmetics	08/16/2023	Batch record - every batch
Pure Simple Products	Food and Cosmetics	08/16/2023	Written procedures - holding
Pure Simple Products	Drugs	08/16/2023	Registration
Pure Simple Products	Drugs	08/16/2023	Procedures - calibrating instruments
Pure Simple Products	Drugs	08/16/2023	Specifications - component identity
Pure Simple Products	Drugs	08/16/2023	Specifications - labels, packaging
Pure Simple Products	Drugs	08/16/2023	Specifications - contamination limits
Pure Simple Products	Drugs	08/16/2023	Specifications - identity, purity, strength, composition
Pure Simple Products	Drugs	08/16/2023	Written procedures - quality control operations
Pure Simple Products	Drugs	08/16/2023	Written procedures - components
Pure Simple Products	Drugs	08/16/2023	Master manufacturing record - unique formulation
Pure Simple Products	Drugs	08/16/2023	Master manufacturing record-specifications; packaged, label
Pure Simple Products	Drugs	08/16/2023	Master manufacturing record theoretical and expected yield
Pure Simple Products	Drugs	08/16/2023	Packaging description, representative label
Pure Simple Products	Drugs	08/16/2023	Master manufacturing record - sampling, tests, examinations
Pure Simple Products	Drugs	08/16/2023	Master manufacturing record - specific actions; quality
Pure Simple Products	Drugs	08/16/2023	Corrective action plans
Pure Simple Products	Drugs	08/16/2023	Batch record - every batch
Pure Simple Products	Drugs	08/16/2023	Written procedures - holding
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Registration
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Specifications - component identity
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Specifications - labels, packaging
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Specifications - contamination limits
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Specifications - identity, purity, strength, composition
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Component - verify identity, dietary ingredient
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Component - qualify supplier
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Reserve sample - collect, hold
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Written procedures - quality control operations
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Master manufacturing record - sampling, tests, examinations
TC Elderberry, LLC	Food and Cosmetics	08/17/2023	Batch record - every batch