NW Houston News

There were 51 companies in cities associated with Harris County that received FDA citations as a result of 55 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 22.7% decrease from the number of companies cited in the previous year.

Of the 143 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 the Devices sector.

Of the companies cited, 45 should take voluntary actions to correct their managing operations (88.2%). Additionally, six companies had to take regulatory and/or administrative actions (11.8%).

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
AF Import & Wholesale Company	Food and Cosmetics	06/06/2023	Develop FSVP
AF Import & Wholesale Company	Food and Cosmetics	06/06/2023	LACF compliance
AF Import & Wholesale Company	Food and Cosmetics	06/06/2023	Supplier approval - document
AF Import & Wholesale Company	Food and Cosmetics	06/06/2023	Approved supplier procedures - importer established
AF Import & Wholesale Company	Food and Cosmetics	06/06/2023	Verification activity - appropriate
AF Import & Wholesale Company	Food and Cosmetics	06/06/2023	Verification activity before import, periodically
AMP International, Inc.	Food and Cosmetics	05/22/2023	Hazard analysis written
AMP International, Inc.	Food and Cosmetics	05/22/2023	Evaluation - performance, risk
AMP International, Inc.	Food and Cosmetics	05/22/2023	Approved supplier procedures - importer established
AMP International, Inc.	Food and Cosmetics	05/22/2023	Unapproved supplier procedures - importer established
AMP International, Inc.	Food and Cosmetics	05/22/2023	Verification activity assurance
Afrilink Services, LLC	Food and Cosmetics	08/08/2023	Develop FSVP
Almadina Supermarket, LLC	Food and Cosmetics	06/05/2023	Develop FSVP
Almadina Supermarket, LLC	Food and Cosmetics	06/05/2023	Identification - entry
Aracely Express, Inc.	Food and Cosmetics	11/20/2023	Written procedures - pest control
Aracely Express, Inc.	Food and Cosmetics	11/20/2023	Reserve sample - collect, hold
Aracely Express, Inc.	Food and Cosmetics	11/20/2023	Written procedures - holding
Aracely Express, Inc.	Food and Cosmetics	11/20/2023	Records - returned dietary supplement: written procedures
Aracely Express, Inc.	Food and Cosmetics	11/20/2023	Written procedures - product complaint; review, investigate
Arya Trading, LLC	Food and Cosmetics	06/28/2023	Develop FSVP
Blue Nile Trading, LLC	Food and Cosmetics	06/20/2023	Develop FSVP
Cardionics, Inc.	Devices	08/30/2023	Training - Lack of or inadequate procedures
Cardionics, Inc.	Devices	08/30/2023	Product rework adverse effects {see also 820.184}
Cordialsa USA, Inc.	Food and Cosmetics	04/06/2023	Verification activity before import, periodically
Cordialsa USA, Inc.	Food and Cosmetics	04/06/2023	Record - translate to English
Cotija Avocados, LLC	Food and Cosmetics	06/21/2023	Develop FSVP
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
DL International, LLC	Food and Cosmetics	05/11/2023	Record - translate to English
Forcemech International, LLC	Devices	04/06/2023	Labeling inspection - UDI
Forcemech International, LLC	Devices	04/06/2023	DMR - not or inadequately maintained
Forcemech International, LLC	Devices	04/06/2023	Servicing - Lack of or inadequate procedures
Four Titans, LLC	Food and Cosmetics	06/16/2023	Develop FSVP
Fumage International, Corp.	Food and Cosmetics	08/15/2023	Develop FSVP
GPI USA, Inc.	Biologics	08/25/2023	Design verification - Lack of or inadequate procedures
GPI USA, Inc.	Biologics	08/25/2023	Lack of or inadequate procedures
GPI USA, Inc.	Devices	08/25/2023	Design verification - Lack of or inadequate procedures
GPI USA, Inc.	Devices	08/25/2023	Lack of or inadequate procedures
Global Imports Origins	Food and Cosmetics	05/02/2023	Develop FSVP
Gokul Corporation	Food and Cosmetics	03/20/2023	Develop FSVP
Gotera, Inc.	Food and Cosmetics	05/12/2023	Develop FSVP
Gotera, Inc.	Food and Cosmetics	05/12/2023	Evaluation - performance, risk
Gotera, Inc.	Food and Cosmetics	05/12/2023	Approved supplier procedures - importer established
Gotera, Inc.	Food and Cosmetics	05/12/2023	Verification activity assurance
Gotera, Inc.	Food and Cosmetics	05/12/2023	Verification activity before import, periodically
Gotera, Inc.	Food and Cosmetics	05/12/2023	Identification - entry
Grace Supply, Inc.	Food and Cosmetics	09/06/2023	Develop FSVP
Grace Supply, Inc.	Food and Cosmetics	09/06/2023	Hazard analysis biological, chemical, physical
Grace Supply, Inc.	Food and Cosmetics	09/06/2023	Onsite audit
Grace Supply, Inc.	Food and Cosmetics	09/06/2023	Verification activity before import, periodically
Grace Supply, Inc.	Food and Cosmetics	09/06/2023	Written assurance - supplier: qualified facility, farm, shell egg producer
Grace Supply, Inc.	Food and Cosmetics	02/16/2023	Develop FSVP
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Written procedures - pest control
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Specifications - identity, purity, strength, composition
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Written procedure quality control operations material review
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Written procedures - labeling operations
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Written procedures -packaging operations
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Written procedures - holding
Greenworld Imports, LLC	Food and Cosmetics	05/16/2023	Written procedures - returned dietary supplement
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Importer verification
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Develop FSVP
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Hazard analysis written
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Evaluation - performance, risk
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Approved supplier procedures - importer established
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Supplier verification - establish written procedures
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Verification activity assurance
ITC Global Trading, Inc.	Food and Cosmetics	02/02/2023	Verification activity before import, periodically
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Hazard analysis biological, chemical, physical
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Evaluation - performance, risk
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Supplier approval - document
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Continue to import, change activities
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Revaluate - new information
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Verification activity - appropriate
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Verification activity before import, periodically
J&R Produce, Inc.	Food and Cosmetics	02/17/2023	Identification - entry
JJR Global, Inc.	Food and Cosmetics	08/10/2023	Develop FSVP
Junior Alvarado's Produce Corporation	Food and Cosmetics	02/02/2023	Develop FSVP
Just Made Foods, LLC	Food and Cosmetics	02/03/2023	HACCP plan - critical control points not listed
Just Made Foods, LLC	Food and Cosmetics	02/03/2023	Verification activities - minimum
LA Ofrenda, Inc.	Food and Cosmetics	01/24/2023	Develop FSVP
La Juna, Inc.	Food and Cosmetics	01/13/2023	Develop FSVP
LaRuche Imports, Inc.	Food and Cosmetics	05/31/2023	HACCP plan implementation
LaRuche Imports, Inc.	Food and Cosmetics	05/31/2023	Monitoring - adequacy
LaRuche Imports, Inc.	Food and Cosmetics	05/31/2023	Sanitation monitoring
Lone Star Medical Products, Inc.	Devices	04/27/2023	Incorrect translation to production specifications
Lone Star Medical Products, Inc.	Devices	04/27/2023	Software validation for automated processes
Lone Star Medical Products, Inc.	Devices	04/27/2023	Lack of or inadequate receiving acceptance procedures
Lone Star Medical Products, Inc.	Devices	04/27/2023	Lack of or inadequate procedures
Lone Star Medical Products, Inc.	Devices	04/27/2023	Records of complaint investigation
Los Pinos Bakery, LLC.	Food and Cosmetics	02/09/2023	Personnel
Los Pinos Bakery, LLC.	Food and Cosmetics	02/09/2023	Sanitary operations - Plant maintenance
Los Pinos Bakery, LLC.	Food and Cosmetics	02/09/2023	Pest control
Mama Mata, LLC	Food and Cosmetics	04/12/2023	Develop FSVP
Market 5201, LLC	Food and Cosmetics	04/12/2023	Verification activity - appropriate
Meditco, Inc.	Food and Cosmetics	11/15/2023	Develop FSVP
Mega Harvest Corporation	Food and Cosmetics	10/25/2023	Develop FSVP
Minland of Texas, Inc.	Food and Cosmetics	04/14/2023	Develop FSVP
Minland of Texas, Inc.	Food and Cosmetics	10/06/2023	Develop FSVP
Monocacy Trading Group, LLC	Food and Cosmetics	09/21/2023	Develop FSVP
Neurogenesis, Inc.	Food and Cosmetics	09/20/2023	Written procedure quality control operations material review
Novaspice	Food and Cosmetics	02/21/2023	Evaluation - performance, risk
Novaspice	Food and Cosmetics	02/21/2023	Supplier verification - establish written procedures
Novaspice	Food and Cosmetics	02/21/2023	Verification activity assurance
Novaspice	Food and Cosmetics	02/21/2023	Verification activity before import, periodically
Novaspice	Food and Cosmetics	02/21/2023	Identification - entry
Prime Foreign Trade	Food and Cosmetics	05/15/2023	Develop FSVP
R & R Produce	Food and Cosmetics	09/08/2023	Develop FSVP
R & R Produce	Food and Cosmetics	09/08/2023	Identification - entry
Ragasa International, LLC	Food and Cosmetics	11/21/2023	Hazard analysis biological, chemical, physical
Ragasa International, LLC	Food and Cosmetics	11/21/2023	Approved supplier procedures - importer established
Rash Catering Services, LLC	Food and Cosmetics	03/31/2023	Develop FSVP
Regino Produce, LLC	Food and Cosmetics	10/27/2023	Develop FSVP
S I Ventures 1, LLC	Food and Cosmetics	09/26/2023	Verification activity frequency
S I Ventures 1, LLC	Food and Cosmetics	09/26/2023	Verification activity - appropriate
S I Ventures 1, LLC	Food and Cosmetics	03/17/2023	Develop FSVP
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
Sharps Compliance, Inc.	Devices	01/31/2023	Incorrect translation to production specifications
Sharps Compliance, Inc.	Devices	01/31/2023	Design changes - Lack of or Inadequate Procedures
Sharps Compliance, Inc.	Devices	01/31/2023	Lack of or inadequate procedures - Acceptance activities
Sharps Compliance, Inc.	Devices	01/31/2023	Nonconforming product, Lack of or inadequate procedures
Sharps Compliance, Inc.	Devices	01/31/2023	Documentation
Sharps Compliance, Inc.	Devices	01/31/2023	Lack of or inadequate procedures for labeling
Sharps Compliance, Inc.	Devices	01/31/2023	DHR content
Sharps Compliance, Inc.	Devices	01/31/2023	Records of complaint investigation
Sharps Compliance, Inc.	Devices	01/31/2023	Sampling methods - Lack of or inadequate procedures
Tropical Growers Direct, LLC	Food and Cosmetics	03/03/2023	Develop FSVP
Us Gulf Coast Trading Company, Inc.	Food and Cosmetics	08/15/2023	Grounds
Us Gulf Coast Trading Company, Inc.	Food and Cosmetics	08/15/2023	Sanitary operations - Plant maintenance
Us Gulf Coast Trading Company, Inc.	Food and Cosmetics	08/15/2023	Toxic chemicals - Identified, held, stored
Us Gulf Coast Trading Company, Inc.	Food and Cosmetics	08/15/2023	Pest control
Us Gulf Coast Trading Company, Inc.	Food and Cosmetics	08/15/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Us Gulf Coast Trading Company, Inc.	Food and Cosmetics	08/15/2023	Storage and Distribution
Visa Fruit, LLC	Food and Cosmetics	09/12/2023	Hazard analysis written
Visa Fruit, LLC	Food and Cosmetics	09/12/2023	Approved supplier procedures - importer established
Visa Fruit, LLC	Food and Cosmetics	09/12/2023	Supplier verification - establish written procedures
Visa Fruit, LLC	Food and Cosmetics	09/12/2023	Verification activity assurance
Visa Fruit, LLC	Food and Cosmetics	09/12/2023	Verification activity before import, periodically
Visa Fruit, LLC	Food and Cosmetics	09/12/2023	Record - translate to English
Walker Coffee Trading, L. P.	Food and Cosmetics	10/16/2023	Hazard analysis written