WC Wisconsin News

There were two companies in cities associated with Pepin 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.

The citations in the county include:

• You did not establish an identity specification for each component.
• You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
• You did not make and keep receiving records for components, packaging and labels.

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

Both companies cited should take voluntary actions to correct their managing operations.

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
Jenny Lind Bakery, Inc.	Food and Cosmetics	01/25/2023	Sanitation of food-contact surfaces - Frequency
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Specifications - component identity
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Specifications - identity, purity, strength, composition
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Records - receiving; components, packaging, labels, products
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Master manufacturing record - unique formulation
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Batch record - complete
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Written procedures - holding
Painted Outlaw Ranch	Food and Cosmetics	02/09/2023	Personnel - quality control operations; identified