SW Houston News

There were two companies in a city associated with Waller 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 a 33.3% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement.
• You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
• You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.

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
Curam Health, LLC	Food and Cosmetics	09/27/2023	Production, process controls - implement
Curam Health, LLC	Food and Cosmetics	09/27/2023	Specifications - identity, purity, strength, composition
Curam Health, LLC	Food and Cosmetics	09/27/2023	Reserve sample - collect, hold
Curam Health, LLC	Food and Cosmetics	09/27/2023	Quality control - components, approve, release
Curam Health, LLC	Food and Cosmetics	09/27/2023	Master manufacturing record - each batch
Sharetea Kachow, LLC	Food and Cosmetics	05/08/2023	Develop FSVP
Sharetea Kachow, LLC	Food and Cosmetics	05/08/2023	Very small importer assurances, supplier