FDA issued 51 citations in cities across Medina County in 2024

FDA issued 51 citations in cities across Medina County in 2024
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer — Official Website
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There were 19 companies in a city associated with Medina County that received FDA citations as a result of 19 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 5.6% increase over the number of companies cited in the previous year.

Of the 51 citations issued, the most common citation was ‘You did not develop an FSVP’.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Devices sector.

All of the 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.

According to its website, 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.

Companies Located Within Medina County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
Alpe Fresh International, Inc. Food and Cosmetics 08/08/2024 Develop FSVP
C. H. Guenther & Son, Inc. Food and Cosmetics 12/17/2024 Allergen preventive controls – Implement
Cerealto USA, LLC Food and Cosmetics 05/10/2024 Hazard analysis biological, chemical, physical
Cerealto USA, LLC Food and Cosmetics 05/10/2024 Approved supplier procedures – importer established
Cerealto USA, LLC Food and Cosmetics 05/10/2024 Verification activity – appropriate
Dulces La Molienda Corporation Food and Cosmetics 08/05/2024 Develop FSVP
Frozen Trading Group, LLC Food and Cosmetics 08/12/2024 Develop FSVP
H-E-B San Antonio Retail Support Center Food and Cosmetics 05/31/2024 Process preventive controls – Implement
J & J Pecans, LLC Food and Cosmetics 11/01/2024 Hazard analysis biological, chemical, physical
J & J Pecans, LLC Food and Cosmetics 11/01/2024 Document review entity’s hazard analysis
J & J Pecans, LLC Food and Cosmetics 11/01/2024 Supplier approval – document
J & J Pecans, LLC Food and Cosmetics 11/01/2024 Supplier verification – establish written procedures
J & J Pecans, LLC Food and Cosmetics 11/01/2024 Identification – entry
LA Aldea Distributors, Inc. Food and Cosmetics 08/21/2024 Hazard analysis biological, chemical, physical
LA Aldea Distributors, Inc. Food and Cosmetics 08/21/2024 Approved supplier procedures – importer established
LA Aldea Distributors, Inc. Food and Cosmetics 08/21/2024 Supplier verification – establish written procedures
LA Aldea Distributors, Inc. Food and Cosmetics 08/21/2024 Verification activity assurance
LA Aldea Distributors, Inc. Food and Cosmetics 08/21/2024 Verification activity before import, periodically
Mesquite Gourmet, LLC Food and Cosmetics 10/17/2024 Develop FSVP
Mesquite Gourmet, LLC Food and Cosmetics 10/17/2024 Identification – entry
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Develop FSVP
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Hazard analysis biological, chemical, physical
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Approved supplier procedures – importer established
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Supplier verification – establish written procedures
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Verification activity frequency
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Audit – food safety regulation, plan
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Identification – entry
NatureSweet, Ltd. Food and Cosmetics 11/14/2024 Record – translate to English
Nutriagaves USA, LLC Food and Cosmetics 07/12/2024 Hazard analysis written
Nutriagaves USA, LLC Food and Cosmetics 07/12/2024 Evaluation – performance, risk
Nutriagaves USA, LLC Food and Cosmetics 07/12/2024 Approved supplier procedures – importer established
Oversea Dewied International, Inc. Food and Cosmetics 08/22/2024 Regulatory oversight
Palmex I, Ltd. Food and Cosmetics 11/13/2024 Hazard analysis biological, chemical, physical
Palmex I, Ltd. Food and Cosmetics 11/13/2024 Document review entity’s hazard analysis
Palmex I, Ltd. Food and Cosmetics 11/13/2024 Evaluation – performance, risk
Palmex I, Ltd. Food and Cosmetics 11/13/2024 Verification activity frequency
Palmex I, Ltd. Food and Cosmetics 11/13/2024 Identification – entry
Produce El Amanecer, LLC Food and Cosmetics 08/28/2024 Develop FSVP
Rochal Technologies Devices 08/01/2024 Product rework procedures, Lack of or inadequate procedures
Rochal Technologies Devices 08/01/2024 Lack of or inadequate complaint procedures
Tanoili Avocados, LLC Food and Cosmetics 03/28/2024 Develop FSVP
Tanoili Avocados, LLC Food and Cosmetics 03/28/2024 Record – translate to English
Tissue Transplant Technology, Ltd. Biologics 05/03/2024 Use prior to verification
Tissue Transplant Technology, Ltd. Biologics 05/03/2024 Use of non-sterile reagents
Tissue Transplant Technology, Ltd. Biologics 05/03/2024 Records maintained concurrently
Turn Medical Devices 06/06/2024 Complaints
World Green Nutrition, Inc. Food and Cosmetics 05/09/2024 Specifications – identity, purity, strength, composition
World Green Nutrition, Inc. Food and Cosmetics 05/09/2024 Written procedures – quality control operations
World Green Nutrition, Inc. Food and Cosmetics 05/09/2024 Written procedures – holding
World Green Nutrition, Inc. Food and Cosmetics 05/09/2024 Written procedures – returned dietary supplement
World Green Nutrition, Inc. Food and Cosmetics 05/09/2024 Written procedures – product complaint


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