South Bay SD News

There were 57 companies in cities associated with San Diego County that received FDA citations as a result of 59 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 5% decrease from the number of companies cited in the previous year.

Of the 206 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, 52 should take voluntary actions to correct their managing operations (91.2%). Additionally, seven companies had to take regulatory and/or administrative actions (12.3%).

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
ACI Medical, LLC	Devices	08/17/2023	DMR - not or inadequately maintained
ACI Medical, LLC	Devices	08/17/2023	DHR - UDI not included
Abamex Distributors	Food and Cosmetics	09/25/2023	Develop FSVP
Anesthesia Associates, Inc.	Devices	12/18/2023	Design history file
Anesthesia Associates, Inc.	Devices	12/18/2023	Purchasing controls, Lack of or inadequate procedures
Anesthesia Associates, Inc.	Devices	12/18/2023	Lack of or inadequate procedures - Acceptance activities
Anesthesia Associates, Inc.	Devices	12/18/2023	Lack of or inadequate procedures
Anesthesia Associates, Inc.	Devices	12/18/2023	DMR - not or inadequately maintained
Anesthesia Associates, Inc.	Devices	12/18/2023	Lack of or inadequate DHR procedures
Anesthesia Associates, Inc.	Devices	12/18/2023	Lack of or inadequate complaint procedures
Arch Medical Solutions - Escondido, LLC	Devices	04/07/2023	Investigation of device failures
Around the World Trading, Inc.	Food and Cosmetics	08/03/2023	Develop FSVP
Baja Best Distributing, Inc.	Food and Cosmetics	06/28/2023	Develop FSVP
California Bread Company	Food and Cosmetics	11/28/2023	Sanitary operations - Plant sanitation
California Bread Company	Food and Cosmetics	11/28/2023	Equipment and utensils - Design and maintenance
California Bread Company	Food and Cosmetics	11/28/2023	Hazard analysis - Identification of hazard
California Bread Company	Food and Cosmetics	11/28/2023	Sanitation preventive controls - Implement
California Bread Company	Food and Cosmetics	11/28/2023	Allergen preventive controls - Appropriate (Adequate)
California Bread Company	Food and Cosmetics	11/28/2023	Sanitation preventive controls - Appropriate (Adequate)
California Bread Company	Food and Cosmetics	11/28/2023	Supply-chain program - Records
California Fertility Experts, Inc.	Biologics	08/25/2023	Manufacturer instructions not followed
California Splendor, Inc.	Food and Cosmetics	08/18/2023	Sanitation preventive controls - Appropriate (Adequate)
California Splendor, Inc.	Food and Cosmetics	08/18/2023	Supply-chain program - Assurance (Adequate)
Cazares Del Golfo Produce	Food and Cosmetics	08/23/2023	Develop FSVP
Coliman Produce, Inc.	Food and Cosmetics	07/10/2023	Develop FSVP
Crown Jewels	Food and Cosmetics	05/24/2023	Verification activity before import, periodically
Desert King International, LLC	Food and Cosmetics	08/28/2023	Hazard analysis biological, chemical, physical
Desert King International, LLC	Food and Cosmetics	08/28/2023	Document review entity's hazard analysis
Desert King International, LLC	Food and Cosmetics	08/28/2023	Evaluation - performance, risk
Desert King International, LLC	Food and Cosmetics	08/28/2023	Approved supplier procedures - importer established
Desert King International, LLC	Food and Cosmetics	08/28/2023	Verification activity assurance
Desert King International, LLC	Food and Cosmetics	08/28/2023	Verification activity before import, periodically
Diamond Orthotic Laboratory	Devices	11/16/2023	Training records
Diamond Orthotic Laboratory	Devices	11/16/2023	Use and removal, Lack of or inadequate procedures
Diamond Orthotic Laboratory	Devices	11/16/2023	Lack of or inadequate final acceptance procedures
Diamond Orthotic Laboratory	Devices	11/16/2023	Complaints
Donald M Brandon, M.D.	Biologics	02/24/2023	Case history records- inadequate or inadequate
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Management review - Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Quality audits - Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Design history file
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Purchasing controls, Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Identification procedures, Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Lack of or inadequate procedures - Acceptance activities
Dr. Joel Kaplan, Inc.	Devices	06/30/2023	Lack of or inadequate complaint procedures
E&H Distributors, LLC	Food and Cosmetics	09/22/2023	Develop FSVP
El Super Leon Ponchin Snacks, Inc.	Food and Cosmetics	06/15/2023	Develop FSVP
Epitope Diagnostics, Inc.	Devices	04/28/2023	Lack of Written MDR Procedures
Epitope Diagnostics, Inc.	Devices	04/28/2023	Lack of or inadequate complaint procedures
Esperanzas Tortillas	Food and Cosmetics	12/22/2023	Sanitary operations - Plant sanitation
Esperanzas Tortillas	Food and Cosmetics	12/22/2023	Manufacturing, processing, packing, holding - Controls
Excellentia Foods	Food and Cosmetics	06/29/2023	Pest control
Gecko Labs, LLC	Devices	12/14/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Gecko Labs, LLC	Devices	12/14/2023	Lack of or inadequate DHR procedures
Gecko Labs, LLC	Devices	12/14/2023	Lack of or inadequate complaint procedures
Gematria Products, Inc.	Food and Cosmetics	11/21/2023	Specifications - component identity
Gematria Products, Inc.	Food and Cosmetics	11/21/2023	Appropriate tests, examinations; certificate of analysis
Gematria Products, Inc.	Food and Cosmetics	11/21/2023	Master manufacturing record - specifications; quality
Guillermo Osuna	Food and Cosmetics	05/25/2023	Develop FSVP
Gustinos Company, LLC	Food and Cosmetics	09/18/2023	Develop FSVP
HRC Fertility	Biologics	05/24/2023	Risk factors, clinical evidence
Hawaiian Fresh Seafood, Inc.	Food and Cosmetics	06/30/2023	HACCP plan implementation
Hawaiian Fresh Seafood, Inc.	Food and Cosmetics	06/30/2023	Food safety hazards
Hawaiian Fresh Seafood, Inc.	Food and Cosmetics	06/30/2023	Corrective action plan
Hawaiian Fresh Seafood, Inc.	Food and Cosmetics	06/30/2023	Verification procedures - adequacy
Hawaiian Fresh Seafood, Inc.	Food and Cosmetics	06/30/2023	Importer verification
Hawaiian Fresh Seafood, Inc.	Veterinary	06/30/2023	HACCP plan implementation
Hawaiian Fresh Seafood, Inc.	Veterinary	06/30/2023	Food safety hazards
Hawaiian Fresh Seafood, Inc.	Veterinary	06/30/2023	Corrective action plan
Hawaiian Fresh Seafood, Inc.	Veterinary	06/30/2023	Verification procedures - adequacy
Hawaiian Fresh Seafood, Inc.	Veterinary	06/30/2023	Importer verification
Hygeia II Medical Group, Inc.	Devices	08/02/2023	Identification procedures, Lack of or inadequate procedures
Hygeia II Medical Group, Inc.	Devices	08/02/2023	Lack of or inadequate receiving acceptance procedures
Hygeia II Medical Group, Inc.	Devices	08/02/2023	Documentation
Hygeia II Medical Group, Inc.	Devices	08/02/2023	Records of complaint investigation
Ikal, LLC	Food and Cosmetics	05/01/2023	Develop FSVP
International JGV, Inc.	Food and Cosmetics	09/12/2023	Develop FSVP
Just About Foods, LLC	Food and Cosmetics	05/03/2023	Develop FSVP
Kresco, LLC	Food and Cosmetics	06/02/2023	Develop FSVP
Las Dos Californias, Inc.	Food and Cosmetics	10/19/2023	Develop FSVP
Las Dos Californias, Inc.	Food and Cosmetics	10/19/2023	Hazard analysis biological, chemical, physical
Las Dos Californias, Inc.	Food and Cosmetics	10/19/2023	Verification activity - appropriate
Leong-Kuba Sea Products, Inc.	Food and Cosmetics	02/07/2023	HACCP plan implementation
Leong-Kuba Sea Products, Inc.	Food and Cosmetics	02/07/2023	Signed and dated
Maos Produce	Food and Cosmetics	03/08/2023	Develop FSVP
Maos Produce	Food and Cosmetics	10/16/2023	Develop FSVP
Mbgi USA, Inc.	Food and Cosmetics	11/20/2023	Develop FSVP
Moriah Family Produce, LLC	Food and Cosmetics	06/29/2023	Pest control
Moriah Family Produce, LLC	Food and Cosmetics	06/29/2023	Storage and Distribution
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Specifications - component identity
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Specifications-component purity, strength, composition
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Specifications - identity, purity, strength, composition
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Component - qualify supplier
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Quality control - production, process control
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Tests, examinations - scientifically valid
Nature's Supplements, Inc.	Food and Cosmetics	04/05/2023	Quality control operations - specifications; components, packaging, labels
Nutritional Supplement Manufacturers, Inc.	Food and Cosmetics	08/03/2023	Specifications - identity, purity, strength, composition
Nutritional Supplement Manufacturers, Inc.	Food and Cosmetics	08/03/2023	Specifications met identity,purity, strength, comp,; basis
Nutritional Supplement Manufacturers, Inc.	Food and Cosmetics	08/03/2023	Quality control production, process control; material review, disposition
OPMX, LLC	Food and Cosmetics	07/07/2023	Written procedures - quality control operations
OPMX, LLC	Food and Cosmetics	07/07/2023	Written procedures - returned dietary supplement
OPMX, LLC	Food and Cosmetics	07/07/2023	Written procedures - product complaint
OPMX, LLC	Food and Cosmetics	07/07/2023	Personnel - quality control operations; identified
Opera Patisserie, Inc.	Food and Cosmetics	09/27/2023	Sanitary operations - Plant sanitation
Pacira Pharmaceuticals, Inc.	Drugs	04/19/2023	Written calibration / inspection records not kept
Pacira Pharmaceuticals, Inc.	Drugs	04/19/2023	Investigations of discrepancies, failures
Pacira Pharmaceuticals, Inc.	Veterinary	04/19/2023	Written calibration / inspection records not kept
Pacira Pharmaceuticals, Inc.	Veterinary	04/19/2023	Investigations of discrepancies, failures
Provisional Health, Corp.	Food and Cosmetics	04/03/2023	Specifications - component identity
Provisional Health, Corp.	Food and Cosmetics	04/03/2023	Specifications-component purity, strength, composition
Provisional Health, Corp.	Food and Cosmetics	04/03/2023	Specifications - identity, purity, strength, composition
Provisional Health, Corp.	Food and Cosmetics	04/03/2023	QC- required operations equipment, instruments, controls
Provisional Health, Corp.	Food and Cosmetics	04/03/2023	Quality control - reject; specification not met
San Diego Fertility Center, Medical Group, Inc.	Biologics	05/26/2023	Risk factors, clinical evidence
San Diego Seafood, Inc.	Food and Cosmetics	02/16/2023	HACCP plan implementation
San Diego Seafood, Inc.	Food and Cosmetics	02/16/2023	Food safety hazards
San Diego Seafood, Inc.	Food and Cosmetics	02/16/2023	Records - content
San Diego Seafood, Inc.	Food and Cosmetics	02/16/2023	Sanitation monitoring
Societal Cdmo San Diego, LLC	Drugs	01/25/2023	Procedures not in writing, fully followed
Societal Cdmo San Diego, LLC	Drugs	01/25/2023	Buildings of Suitable Size, Construction, Location
Societal Cdmo San Diego, LLC	Drugs	01/25/2023	Investigations of discrepancies, failures
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Specifications - component identity
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Specifications - identity, purity, strength, composition
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Written procedures - quality control operations
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Master manufacturing record - unique formulation
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Batch record - every batch
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Hazard analysis - Identification of hazard
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	Sanitation monitoring
Sol-ti, Inc.	Food and Cosmetics	10/05/2023	HACCP plan - not validated
Sol-ti, Inc.	Veterinary	10/05/2023	Specifications - component identity
Sol-ti, Inc.	Veterinary	10/05/2023	Specifications - identity, purity, strength, composition
Sol-ti, Inc.	Veterinary	10/05/2023	Written procedures - quality control operations
Sol-ti, Inc.	Veterinary	10/05/2023	Master manufacturing record - unique formulation
Sol-ti, Inc.	Veterinary	10/05/2023	Batch record - every batch
Sol-ti, Inc.	Veterinary	10/05/2023	Hazard analysis - Identification of hazard
Sol-ti, Inc.	Veterinary	10/05/2023	Sanitation monitoring
Sol-ti, Inc.	Veterinary	10/05/2023	HACCP plan - not validated
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Specifications - component identity
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Specifications - identity, purity, strength, composition
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Written procedures - quality control operations
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Master manufacturing record - unique formulation
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Batch record - every batch
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Hazard analysis - Identification of hazard
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Sanitation monitoring
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	All hazards not considered
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	HACCP plan not implemented
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	HACCP plan - food hazards not listed
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	HACCP plan - verify procedures / frequency - none listed
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	Calibration, testing - no records
Sol-ti, Inc.	Food and Cosmetics	02/08/2023	HACCP plan - not validated
Sol-ti, Inc.	Veterinary	02/08/2023	Specifications - component identity
Sol-ti, Inc.	Veterinary	02/08/2023	Specifications - identity, purity, strength, composition
Sol-ti, Inc.	Veterinary	02/08/2023	Written procedures - quality control operations
Sol-ti, Inc.	Veterinary	02/08/2023	Master manufacturing record - unique formulation
Sol-ti, Inc.	Veterinary	02/08/2023	Batch record - every batch
Sol-ti, Inc.	Veterinary	02/08/2023	Hazard analysis - Identification of hazard
Sol-ti, Inc.	Veterinary	02/08/2023	Sanitation monitoring
Sol-ti, Inc.	Veterinary	02/08/2023	All hazards not considered
Sol-ti, Inc.	Veterinary	02/08/2023	HACCP plan not implemented
Sol-ti, Inc.	Veterinary	02/08/2023	HACCP plan - food hazards not listed
Sol-ti, Inc.	Veterinary	02/08/2023	HACCP plan - verify procedures / frequency - none listed
Sol-ti, Inc.	Veterinary	02/08/2023	Calibration, testing - no records
Sol-ti, Inc.	Veterinary	02/08/2023	HACCP plan - not validated
Spinergy, Inc.	Devices	08/15/2023	Lack of Written MDR Procedures
Spinergy, Inc.	Devices	08/15/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Spinergy, Inc.	Devices	08/15/2023	Documentation
Spinergy, Inc.	Devices	08/15/2023	DHR content
Supreme Fruit Produce, Inc.	Food and Cosmetics	02/02/2023	Develop FSVP
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Specifications - component identity
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Specifications-component purity, strength, composition
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Specifications - labels, packaging
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Specifications - identity, purity, strength, composition
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Written procedures - components
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Packaging description, representative label
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Batch record - identifier; packaging
Supreme Lab Nutrition, LLC	Food and Cosmetics	08/25/2023	Quality control - processes, specifications, written procedures
Surgitech, Inc.	Devices	08/10/2023	Lack of System for Timely Submission of Reports
Surgitech, Inc.	Devices	08/10/2023	Management review - defined interval, sufficient frequency
Surgitech, Inc.	Devices	08/10/2023	Quality Audits - defined intervals
Surgitech, Inc.	Devices	08/10/2023	Training - Lack of or inadequate procedures
Surgitech, Inc.	Devices	08/10/2023	Design plans- updated
Surgitech, Inc.	Devices	08/10/2023	Acceptable supplier records, inadequate records
Surgitech, Inc.	Devices	08/10/2023	Equipment control activity documentation
Surgitech, Inc.	Devices	08/10/2023	Lack of or inadequate procedures
Surgitech, Inc.	Devices	08/10/2023	DHR - not or inadequately maintained
Surgitech, Inc.	Devices	08/10/2023	Complaints
Tandem Diabetes Care, Inc.	Devices	03/23/2023	Lack of or inadequate procedures
Trade Rooster, Inc.	Food and Cosmetics	08/31/2023	Develop FSVP
Trade Rooster, Inc.	Food and Cosmetics	08/31/2023	Supplier approval - document
Trade Rooster, Inc.	Food and Cosmetics	08/31/2023	Verification activity - appropriate
Trade Rooster, Inc.	Food and Cosmetics	08/31/2023	Verification activity before import, periodically
True Function Laboratory, Inc.	Devices	08/07/2023	Management review - Lack of or inadequate procedures
True Function Laboratory, Inc.	Devices	08/07/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
True Function Laboratory, Inc.	Devices	08/07/2023	Lack of or inadequate procedures - Acceptance activities
True Function Laboratory, Inc.	Devices	08/07/2023	Nonconforming product, Lack of or inadequate procedures
True Function Laboratory, Inc.	Devices	08/07/2023	Documentation
True Function Laboratory, Inc.	Devices	08/07/2023	Lack of or inadequate DHR procedures
True Function Laboratory, Inc.	Devices	08/07/2023	Review and evaluation for investigation
Vidasoy	Food and Cosmetics	03/30/2023	Sanitary operations - Plant maintenance
Vidasoy	Food and Cosmetics	03/30/2023	Pest control
Vidasoy	Food and Cosmetics	03/30/2023	Manufacturing, processing, packing, holding - Controls
Vidasoy	Food and Cosmetics	03/30/2023	Procedural requirements
Vmaco, Inc.	Food and Cosmetics	06/08/2023	Develop FSVP
Zuland Distributor, CORP	Food and Cosmetics	09/28/2023	Develop FSVP
Zuland Distributor, CORP	Food and Cosmetics	09/28/2023	Verification activity - appropriate
Zuland Distributor, CORP	Food and Cosmetics	09/28/2023	Verification activity before import, periodically
Zuland Distributor, CORP	Food and Cosmetics	09/28/2023	Audit - food safety regulation, plan