Mid City Times

There were two companies in cities associated with Dallas County that received FDA citations as a result of two inspections conducted in the county in May, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

• You did not develop an FSVP.
• You did not have a written hazard analysis.
• You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.

Both companies cited were involved in either Food and Cosmetics or Drugs sectors.

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
Bonafide Innovations, LLC	Drugs	05/06/2024	GMP Training Frequency
Bonafide Innovations, LLC	Drugs	05/06/2024	Buildings of Suitable Size, Construction, Location
Bonafide Innovations, LLC	Drugs	05/06/2024	Written procedures not established/followed
FMT Services, LLC	Food and Cosmetics	05/02/2024	Develop FSVP
FMT Services, LLC	Food and Cosmetics	05/02/2024	Hazard analysis written
FMT Services, LLC	Food and Cosmetics	05/02/2024	Supplier approval - document
FMT Services, LLC	Food and Cosmetics	05/02/2024	Reevaluate - 3 years
FMT Services, LLC	Food and Cosmetics	05/02/2024	Approved supplier procedures - importer established
FMT Services, LLC	Food and Cosmetics	05/02/2024	Supplier verification - establish written procedures
FMT Services, LLC	Food and Cosmetics	05/02/2024	Verification activity assurance
FMT Services, LLC	Food and Cosmetics	05/02/2024	Verification activity before import, periodically