Houston Republic

There were three companies in cities associated with Harris County that received FDA citations as a result of three inspections 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 develop an FSVP.
• You did not ensure that your electronic mail address and the unique facility identifier recognized as acceptable by FDA were provided electronically when filing entry with the U.S. Customs and Border Protection.
• The accompanying records for HCT/Ps included the donor's name and personal information that might identify the donor.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%).

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
Family Fertility Center	Biologics	01/30/2024	Name and personal info on accompanying records
San Martin Distributing, Inc.	Food and Cosmetics	01/04/2024	Written procedures - holding
Sca Imports & Distribution, LLC	Food and Cosmetics	01/11/2024	Develop FSVP
Sca Imports & Distribution, LLC	Food and Cosmetics	01/11/2024	Identification - entry