OKC Standard

There was one company in a city associated with Pottawatomie County that received FDA citations as a result of one inspection conducted in the county in January, 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 month.

The citations in the county include:

• 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.
• You did not conduct appropriate tests or examinations to determine compliance with the specifications established for identity, purity, strength and composition.
• Your quality control personnel did not conduct a material review and make a disposition decision for a specification established for the production and process control system that was not met.

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
Ultra Botanica, LLC	Food and Cosmetics	01/19/2024	Component - qualify supplier
Ultra Botanica, LLC	Food and Cosmetics	01/19/2024	Specifications met - test, examinations; compliance
Ultra Botanica, LLC	Food and Cosmetics	01/19/2024	QC production, process control; material review, disposition
Ultra Botanica, LLC	Food and Cosmetics	01/19/2024	Manufacturing operations - prevent contamination