South SFV Today

There were 25 companies in cities associated with Santa Clara County that received FDA citations as a result of 26 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 38.9% increase over the number of companies cited in the previous year.

Of the 75 citations issued, the most common citations were 'You did not develop an FSVP' and 'You did not exclude pests from your food plant to protect against contamination of food'.

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, 24 should take voluntary actions to correct their managing operations (96%). Additionally, two companies had to take regulatory and/or administrative actions (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
Asap Sons Group, Inc.	Food and Cosmetics	06/23/2023	Develop FSVP
Asiana Produce, Inc.	Food and Cosmetics	03/30/2023	Grounds
Asiana Produce, Inc.	Food and Cosmetics	03/30/2023	Sanitary operations - Plant maintenance
Asiana Produce, Inc.	Food and Cosmetics	03/30/2023	Pest control
Avantec Vascular Corporation	Devices	01/26/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Bigfoot Biomedical	Devices	03/21/2023	Individual Report of Malfunction
Bigfoot Biomedical	Devices	03/21/2023	Lack of or inadequate complaint procedures
Bondsforever, Inc.	Food and Cosmetics	02/06/2023	Qualifications of individuals
Cardiva Medical, Inc.	Devices	07/21/2023	Quality System Procedures
Cardiva Medical, Inc.	Devices	07/21/2023	Training records
Cardiva Medical, Inc.	Devices	07/21/2023	Documentation
Cardiva Medical, Inc.	Devices	07/21/2023	Records of complaint investigation
Cirtec Medical	Devices	03/08/2023	Lack of or inadequate procedures
Embolx, Inc.	Devices	01/19/2023	Lack of System for Event Evaluations
Embolx, Inc.	Devices	01/19/2023	Management representative implementing the quality system
Embolx, Inc.	Devices	01/19/2023	Quality audits - auditor independence
Embolx, Inc.	Devices	01/19/2023	Documented evaluation
Embolx, Inc.	Devices	01/19/2023	Documentation
Embolx, Inc.	Devices	01/19/2023	Records of complaint investigation
Evershing International Trading, Inc.	Food and Cosmetics	09/08/2023	Importer verification
Grandy Ventures, Inc.	Food and Cosmetics	08/17/2023	HACCP plan implementation
Intuitive Surgical, Inc.	Devices	12/14/2023	Lack of or inadequate procedures
L&D Fish Corporation	Food and Cosmetics	08/18/2023	Hazard analysis
L&D Fish Corporation	Food and Cosmetics	08/18/2023	No HACCP plan
L&D Fish Corporation	Food and Cosmetics	08/18/2023	Sanitation monitoring
LimFlow, Inc.	Devices	05/15/2023	Sponsors' general responsibilities
LimFlow, Inc.	Devices	05/15/2023	Sponsor securing investigator compliance
Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health	Biologics	04/27/2023	Manufacturer instructions not followed
Mai, PHU Van	Food and Cosmetics	05/24/2023	Very small importer assurances, supplier
North Coast Medical, Inc.	Devices	08/28/2023	Report of risk to health
North Coast Medical, Inc.	Devices	08/28/2023	Review and evaluation for investigation
Ocomar Enterprises, LLC	Food and Cosmetics	08/18/2023	Records entries - timing
Ocomar Enterprises, LLC	Food and Cosmetics	08/18/2023	Sanitation monitoring
Outset Medical, Inc.	Devices	02/10/2023	Report of Death or Serious Injury
Outset Medical, Inc.	Devices	02/10/2023	Design validation - software validation not performed
Outset Medical, Inc.	Devices	02/10/2023	Procedures for product review,disposition lack of/inadequate
Outset Medical, Inc.	Devices	02/10/2023	Documentation
Robles Bros, Inc.	Food and Cosmetics	05/18/2023	Sanitary operations - Plant sanitation
SFTC, Inc.	Food and Cosmetics	11/28/2023	Qualifications of individuals
SFTC, Inc.	Food and Cosmetics	11/28/2023	Sanitary operations - Plant maintenance
SFTC, Inc.	Food and Cosmetics	06/23/2023	Develop FSVP
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Plant construction and design
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Pest control
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Sanitation of food-contact surfaces - Frequency
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Sanitary facilities and controls
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Equipment and utensils - Design and maintenance
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Plant operations - Precautions
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Hazard analysis - Identification of hazard
Sai Foods, Inc.	Food and Cosmetics	02/06/2023	Supply-chain program - Establish
T & S Produce Company, Inc.	Food and Cosmetics	03/01/2023	Carrier - Safe Transport
T & S Produce Company, Inc.	Food and Cosmetics	03/01/2023	Personnel
T & S Produce Company, Inc.	Food and Cosmetics	03/01/2023	Plant construction and design
T & S Produce Company, Inc.	Food and Cosmetics	03/01/2023	Sanitary operations - Plant maintenance
T & S Produce Company, Inc.	Food and Cosmetics	03/01/2023	Pest control
Theos Medical Systems, Inc.	Devices	06/16/2023	Management representative implementing the quality system
Theos Medical Systems, Inc.	Devices	06/16/2023	Documentation
Theos Medical Systems, Inc.	Devices	06/16/2023	Review and evaluation for investigation
Verka USA, Inc.	Food and Cosmetics	05/01/2023	Develop FSVP
Wedgewood Connect, LLC	Drugs	11/17/2023	Approve or reject components, products
Wedgewood Connect, LLC	Drugs	11/17/2023	Training--operations, GMPs, written procedures
Wedgewood Connect, LLC	Drugs	11/17/2023	Defined areas of adequate size for operations
Wedgewood Connect, LLC	Drugs	11/17/2023	Environmental Monitoring System
Wedgewood Connect, LLC	Drugs	11/17/2023	Cleaning System
Wedgewood Connect, LLC	Drugs	11/17/2023	Procedures for sterile drug products
Wedgewood Connect, LLC	Drugs	11/17/2023	No written record of investigation
Wedgewood Connect, LLC	Drugs	11/17/2023	Drug product labels, fails to include
Wedgewood Connect, LLC	Veterinary	11/17/2023	Approve or reject components, products
Wedgewood Connect, LLC	Veterinary	11/17/2023	Training--operations, GMPs, written procedures
Wedgewood Connect, LLC	Veterinary	11/17/2023	Defined areas of adequate size for operations
Wedgewood Connect, LLC	Veterinary	11/17/2023	Environmental Monitoring System
Wedgewood Connect, LLC	Veterinary	11/17/2023	Cleaning System
Wedgewood Connect, LLC	Veterinary	11/17/2023	Procedures for sterile drug products
Wedgewood Connect, LLC	Veterinary	11/17/2023	No written record of investigation
Wedgewood Connect, LLC	Veterinary	11/17/2023	Drug product labels, fails to include