How many companies in cities across Orange County received FDA citations in Q3?

Mark Raza Principal Deputy Chief Counsel - FDA | Official Website

By Orlando Standard

Oct 21, 2024

There was one company in a city associated with Orange County that received FDA citations as a result of one inspection conducted in the county over the third quarter of 2024, 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 quarter.

The citations in the county include:

For component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and limits on contamination to ensure the quality of the dietary supplement.
You did not establish product specifications for identity, purity and composition.
You did not document why an exempted product specification is met without verification by periodically testing the finished batch.

The company cited was involved in the Food and Cosmetics sector.

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.

Companies located within Orange County Cities and the citations they received in Q3

Company Name	Area of Business	Inspection Date	Issue Cited
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Specifications - components
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Specifications - finished dietary supplement
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Documentation specifications met; exempted, periodic testing
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Master manufacturing record - prepared
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Master manufacturing record - record requirements
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Standard reference materials; criteria for selecting
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Examination, testing; established criteria
XYMOGEN, Inc.	Food and Cosmetics	08/13/2024	Examination, testing; scientifically valid