Kitsap Review

There was one company in a city associated with Kitsap County that received FDA citations as a result of one inspection 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 product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
• You did not determine whether you met established limits on contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement.
• You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of their tests or examinations.

The company cited should take a voluntary action to correct its 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
Heron Botanicals, Inc.	Food and Cosmetics	03/28/2023	Specifications - contamination limits
Heron Botanicals, Inc.	Food and Cosmetics	03/28/2023	Specifications met - contamination limits
Heron Botanicals, Inc.	Food and Cosmetics	03/28/2023	Component - qualify supplier
Heron Botanicals, Inc.	Food and Cosmetics	03/28/2023	Master manufacturing record - each batch
Heron Botanicals, Inc.	Food and Cosmetics	03/28/2023	Instructions; specifications; quality
Heron Botanicals, Inc.	Food and Cosmetics	03/28/2023	Tests, examinations - scientifically valid