East Kentucky Times

There was one company in a city associated with Wolfe 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 unchanged from the number of companies cited in the previous year.

The citations in the county include:

• You did not establish component specifications for purity, strength and composition.
• You did not establish limits for contamination that may adulterate or 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 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
PI Pharma, Inc.	Food and Cosmetics	04/11/2023	Specifications-component purity, strength, composition
PI Pharma, Inc.	Food and Cosmetics	04/11/2023	Specifications - contamination limits
PI Pharma, Inc.	Food and Cosmetics	04/11/2023	Specifications - identity, purity, strength, composition
PI Pharma, Inc.	Food and Cosmetics	04/11/2023	Tests, examinations - scientifically valid