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Thursday, October 31, 2024

How many companies in cities across San Diego County received FDA citations in 2023?

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

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.

Companies Located Within San Diego County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
ACI Medical, LLCDevices08/17/2023DMR - not or inadequately maintained
ACI Medical, LLCDevices08/17/2023DHR - UDI not included
Abamex DistributorsFood and Cosmetics09/25/2023Develop FSVP
Anesthesia Associates, Inc.Devices12/18/2023Design history file
Anesthesia Associates, Inc.Devices12/18/2023Purchasing controls, Lack of or inadequate procedures
Anesthesia Associates, Inc.Devices12/18/2023Lack of or inadequate procedures - Acceptance activities
Anesthesia Associates, Inc.Devices12/18/2023Lack of or inadequate procedures
Anesthesia Associates, Inc.Devices12/18/2023DMR - not or inadequately maintained
Anesthesia Associates, Inc.Devices12/18/2023Lack of or inadequate DHR procedures
Anesthesia Associates, Inc.Devices12/18/2023Lack of or inadequate complaint procedures
Arch Medical Solutions - Escondido, LLCDevices04/07/2023Investigation of device failures
Around the World Trading, Inc.Food and Cosmetics08/03/2023Develop FSVP
Baja Best Distributing, Inc.Food and Cosmetics06/28/2023Develop FSVP
California Bread CompanyFood and Cosmetics11/28/2023Sanitary operations - Plant sanitation
California Bread CompanyFood and Cosmetics11/28/2023Equipment and utensils - Design and maintenance
California Bread CompanyFood and Cosmetics11/28/2023Hazard analysis - Identification of hazard
California Bread CompanyFood and Cosmetics11/28/2023Sanitation preventive controls - Implement
California Bread CompanyFood and Cosmetics11/28/2023Allergen preventive controls - Appropriate (Adequate)
California Bread CompanyFood and Cosmetics11/28/2023Sanitation preventive controls - Appropriate (Adequate)
California Bread CompanyFood and Cosmetics11/28/2023Supply-chain program - Records
California Fertility Experts, Inc.Biologics08/25/2023Manufacturer instructions not followed
California Splendor, Inc.Food and Cosmetics08/18/2023Sanitation preventive controls - Appropriate (Adequate)
California Splendor, Inc.Food and Cosmetics08/18/2023Supply-chain program - Assurance (Adequate)
Cazares Del Golfo ProduceFood and Cosmetics08/23/2023Develop FSVP
Coliman Produce, Inc.Food and Cosmetics07/10/2023Develop FSVP
Crown JewelsFood and Cosmetics05/24/2023Verification activity before import, periodically
Desert King International, LLCFood and Cosmetics08/28/2023Hazard analysis biological, chemical, physical
Desert King International, LLCFood and Cosmetics08/28/2023Document review entity's hazard analysis
Desert King International, LLCFood and Cosmetics08/28/2023Evaluation - performance, risk
Desert King International, LLCFood and Cosmetics08/28/2023Approved supplier procedures - importer established
Desert King International, LLCFood and Cosmetics08/28/2023Verification activity assurance
Desert King International, LLCFood and Cosmetics08/28/2023Verification activity before import, periodically
Diamond Orthotic LaboratoryDevices11/16/2023Training records
Diamond Orthotic LaboratoryDevices11/16/2023Use and removal, Lack of or inadequate procedures
Diamond Orthotic LaboratoryDevices11/16/2023Lack of or inadequate final acceptance procedures
Diamond Orthotic LaboratoryDevices11/16/2023Complaints
Donald M Brandon, M.D.Biologics02/24/2023Case history records- inadequate or inadequate
Dr. Joel Kaplan, Inc.Devices06/30/2023Management review - Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.Devices06/30/2023Quality audits - Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.Devices06/30/2023Design history file
Dr. Joel Kaplan, Inc.Devices06/30/2023Purchasing controls, Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.Devices06/30/2023Identification procedures, Lack of or inadequate procedures
Dr. Joel Kaplan, Inc.Devices06/30/2023Lack of or inadequate procedures - Acceptance activities
Dr. Joel Kaplan, Inc.Devices06/30/2023Lack of or inadequate complaint procedures
E&H Distributors, LLCFood and Cosmetics09/22/2023Develop FSVP
El Super Leon Ponchin Snacks, Inc.Food and Cosmetics06/15/2023Develop FSVP
Epitope Diagnostics, Inc.Devices04/28/2023Lack of Written MDR Procedures
Epitope Diagnostics, Inc.Devices04/28/2023Lack of or inadequate complaint procedures
Esperanzas TortillasFood and Cosmetics12/22/2023Sanitary operations - Plant sanitation
Esperanzas TortillasFood and Cosmetics12/22/2023Manufacturing, processing, packing, holding - Controls
Excellentia FoodsFood and Cosmetics06/29/2023Pest control
Gecko Labs, LLCDevices12/14/2023Calibration, Inspection, etc. Procedures Lack of or Inadequ
Gecko Labs, LLCDevices12/14/2023Lack of or inadequate DHR procedures
Gecko Labs, LLCDevices12/14/2023Lack of or inadequate complaint procedures
Gematria Products, Inc.Food and Cosmetics11/21/2023Specifications - component identity
Gematria Products, Inc.Food and Cosmetics11/21/2023Appropriate tests, examinations; certificate of analysis
Gematria Products, Inc.Food and Cosmetics11/21/2023Master manufacturing record - specifications; quality
Guillermo OsunaFood and Cosmetics05/25/2023Develop FSVP
Gustinos Company, LLCFood and Cosmetics09/18/2023Develop FSVP
HRC FertilityBiologics05/24/2023Risk factors, clinical evidence
Hawaiian Fresh Seafood, Inc.Food and Cosmetics06/30/2023HACCP plan implementation
Hawaiian Fresh Seafood, Inc.Food and Cosmetics06/30/2023Food safety hazards
Hawaiian Fresh Seafood, Inc.Food and Cosmetics06/30/2023Corrective action plan
Hawaiian Fresh Seafood, Inc.Food and Cosmetics06/30/2023Verification procedures - adequacy
Hawaiian Fresh Seafood, Inc.Food and Cosmetics06/30/2023Importer verification
Hawaiian Fresh Seafood, Inc.Veterinary06/30/2023HACCP plan implementation
Hawaiian Fresh Seafood, Inc.Veterinary06/30/2023Food safety hazards
Hawaiian Fresh Seafood, Inc.Veterinary06/30/2023Corrective action plan
Hawaiian Fresh Seafood, Inc.Veterinary06/30/2023Verification procedures - adequacy
Hawaiian Fresh Seafood, Inc.Veterinary06/30/2023Importer verification
Hygeia II Medical Group, Inc.Devices08/02/2023Identification procedures, Lack of or inadequate procedures
Hygeia II Medical Group, Inc.Devices08/02/2023Lack of or inadequate receiving acceptance procedures
Hygeia II Medical Group, Inc.Devices08/02/2023Documentation
Hygeia II Medical Group, Inc.Devices08/02/2023Records of complaint investigation
Ikal, LLCFood and Cosmetics05/01/2023Develop FSVP
International JGV, Inc.Food and Cosmetics09/12/2023Develop FSVP
Just About Foods, LLCFood and Cosmetics05/03/2023Develop FSVP
Kresco, LLCFood and Cosmetics06/02/2023Develop FSVP
Las Dos Californias, Inc.Food and Cosmetics10/19/2023Develop FSVP
Las Dos Californias, Inc.Food and Cosmetics10/19/2023Hazard analysis biological, chemical, physical
Las Dos Californias, Inc.Food and Cosmetics10/19/2023Verification activity - appropriate
Leong-Kuba Sea Products, Inc.Food and Cosmetics02/07/2023HACCP plan implementation
Leong-Kuba Sea Products, Inc.Food and Cosmetics02/07/2023Signed and dated
Maos ProduceFood and Cosmetics03/08/2023Develop FSVP
Maos ProduceFood and Cosmetics10/16/2023Develop FSVP
Mbgi USA, Inc.Food and Cosmetics11/20/2023Develop FSVP
Moriah Family Produce, LLCFood and Cosmetics06/29/2023Pest control
Moriah Family Produce, LLCFood and Cosmetics06/29/2023Storage and Distribution
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Specifications - component identity
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Specifications-component purity, strength, composition
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Specifications - identity, purity, strength, composition
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Component - qualify supplier
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Quality control - production, process control
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Tests, examinations - scientifically valid
Nature's Supplements, Inc.Food and Cosmetics04/05/2023Quality control operations - specifications; components, packaging, labels
Nutritional Supplement Manufacturers, Inc.Food and Cosmetics08/03/2023Specifications - identity, purity, strength, composition
Nutritional Supplement Manufacturers, Inc.Food and Cosmetics08/03/2023Specifications met identity,purity, strength, comp,; basis
Nutritional Supplement Manufacturers, Inc.Food and Cosmetics08/03/2023Quality control production, process control; material review, disposition
OPMX, LLCFood and Cosmetics07/07/2023Written procedures - quality control operations
OPMX, LLCFood and Cosmetics07/07/2023Written procedures - returned dietary supplement
OPMX, LLCFood and Cosmetics07/07/2023Written procedures - product complaint
OPMX, LLCFood and Cosmetics07/07/2023Personnel - quality control operations; identified
Opera Patisserie, Inc.Food and Cosmetics09/27/2023Sanitary operations - Plant sanitation
Pacira Pharmaceuticals, Inc.Drugs04/19/2023Written calibration / inspection records not kept
Pacira Pharmaceuticals, Inc.Drugs04/19/2023Investigations of discrepancies, failures
Pacira Pharmaceuticals, Inc.Veterinary04/19/2023Written calibration / inspection records not kept
Pacira Pharmaceuticals, Inc.Veterinary04/19/2023Investigations of discrepancies, failures
Provisional Health, Corp.Food and Cosmetics04/03/2023Specifications - component identity
Provisional Health, Corp.Food and Cosmetics04/03/2023Specifications-component purity, strength, composition
Provisional Health, Corp.Food and Cosmetics04/03/2023Specifications - identity, purity, strength, composition
Provisional Health, Corp.Food and Cosmetics04/03/2023QC- required operations equipment, instruments, controls
Provisional Health, Corp.Food and Cosmetics04/03/2023Quality control - reject; specification not met
San Diego Fertility Center, Medical Group, Inc.Biologics05/26/2023Risk factors, clinical evidence
San Diego Seafood, Inc.Food and Cosmetics02/16/2023HACCP plan implementation
San Diego Seafood, Inc.Food and Cosmetics02/16/2023Food safety hazards
San Diego Seafood, Inc.Food and Cosmetics02/16/2023Records - content
San Diego Seafood, Inc.Food and Cosmetics02/16/2023Sanitation monitoring
Societal Cdmo San Diego, LLCDrugs01/25/2023Procedures not in writing, fully followed
Societal Cdmo San Diego, LLCDrugs01/25/2023Buildings of Suitable Size, Construction, Location
Societal Cdmo San Diego, LLCDrugs01/25/2023Investigations of discrepancies, failures
Sol-ti, Inc.Food and Cosmetics10/05/2023Specifications - component identity
Sol-ti, Inc.Food and Cosmetics10/05/2023Specifications - identity, purity, strength, composition
Sol-ti, Inc.Food and Cosmetics10/05/2023Written procedures - quality control operations
Sol-ti, Inc.Food and Cosmetics10/05/2023Master manufacturing record - unique formulation
Sol-ti, Inc.Food and Cosmetics10/05/2023Batch record - every batch
Sol-ti, Inc.Food and Cosmetics10/05/2023Hazard analysis - Identification of hazard
Sol-ti, Inc.Food and Cosmetics10/05/2023Sanitation monitoring
Sol-ti, Inc.Food and Cosmetics10/05/2023HACCP plan - not validated
Sol-ti, Inc.Veterinary10/05/2023Specifications - component identity
Sol-ti, Inc.Veterinary10/05/2023Specifications - identity, purity, strength, composition
Sol-ti, Inc.Veterinary10/05/2023Written procedures - quality control operations
Sol-ti, Inc.Veterinary10/05/2023Master manufacturing record - unique formulation
Sol-ti, Inc.Veterinary10/05/2023Batch record - every batch
Sol-ti, Inc.Veterinary10/05/2023Hazard analysis - Identification of hazard
Sol-ti, Inc.Veterinary10/05/2023Sanitation monitoring
Sol-ti, Inc.Veterinary10/05/2023HACCP plan - not validated
Sol-ti, Inc.Food and Cosmetics02/08/2023Specifications - component identity
Sol-ti, Inc.Food and Cosmetics02/08/2023Specifications - identity, purity, strength, composition
Sol-ti, Inc.Food and Cosmetics02/08/2023Written procedures - quality control operations
Sol-ti, Inc.Food and Cosmetics02/08/2023Master manufacturing record - unique formulation
Sol-ti, Inc.Food and Cosmetics02/08/2023Batch record - every batch
Sol-ti, Inc.Food and Cosmetics02/08/2023Hazard analysis - Identification of hazard
Sol-ti, Inc.Food and Cosmetics02/08/2023Sanitation monitoring
Sol-ti, Inc.Food and Cosmetics02/08/2023All hazards not considered
Sol-ti, Inc.Food and Cosmetics02/08/2023HACCP plan not implemented
Sol-ti, Inc.Food and Cosmetics02/08/2023HACCP plan - food hazards not listed
Sol-ti, Inc.Food and Cosmetics02/08/2023HACCP plan - verify procedures / frequency - none listed
Sol-ti, Inc.Food and Cosmetics02/08/2023Calibration, testing - no records
Sol-ti, Inc.Food and Cosmetics02/08/2023HACCP plan - not validated
Sol-ti, Inc.Veterinary02/08/2023Specifications - component identity
Sol-ti, Inc.Veterinary02/08/2023Specifications - identity, purity, strength, composition
Sol-ti, Inc.Veterinary02/08/2023Written procedures - quality control operations
Sol-ti, Inc.Veterinary02/08/2023Master manufacturing record - unique formulation
Sol-ti, Inc.Veterinary02/08/2023Batch record - every batch
Sol-ti, Inc.Veterinary02/08/2023Hazard analysis - Identification of hazard
Sol-ti, Inc.Veterinary02/08/2023Sanitation monitoring
Sol-ti, Inc.Veterinary02/08/2023All hazards not considered
Sol-ti, Inc.Veterinary02/08/2023HACCP plan not implemented
Sol-ti, Inc.Veterinary02/08/2023HACCP plan - food hazards not listed
Sol-ti, Inc.Veterinary02/08/2023HACCP plan - verify procedures / frequency - none listed
Sol-ti, Inc.Veterinary02/08/2023Calibration, testing - no records
Sol-ti, Inc.Veterinary02/08/2023HACCP plan - not validated
Spinergy, Inc.Devices08/15/2023Lack of Written MDR Procedures
Spinergy, Inc.Devices08/15/2023Calibration, Inspection, etc. Procedures Lack of or Inadequ
Spinergy, Inc.Devices08/15/2023Documentation
Spinergy, Inc.Devices08/15/2023DHR content
Supreme Fruit Produce, Inc.Food and Cosmetics02/02/2023Develop FSVP
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Specifications - component identity
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Specifications-component purity, strength, composition
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Specifications - labels, packaging
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Specifications - identity, purity, strength, composition
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Written procedures - components
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Packaging description, representative label
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Batch record - identifier; packaging
Supreme Lab Nutrition, LLCFood and Cosmetics08/25/2023Quality control - processes, specifications, written procedures
Surgitech, Inc.Devices08/10/2023Lack of System for Timely Submission of Reports
Surgitech, Inc.Devices08/10/2023Management review - defined interval, sufficient frequency
Surgitech, Inc.Devices08/10/2023Quality Audits - defined intervals
Surgitech, Inc.Devices08/10/2023Training - Lack of or inadequate procedures
Surgitech, Inc.Devices08/10/2023Design plans- updated
Surgitech, Inc.Devices08/10/2023Acceptable supplier records, inadequate records
Surgitech, Inc.Devices08/10/2023Equipment control activity documentation
Surgitech, Inc.Devices08/10/2023Lack of or inadequate procedures
Surgitech, Inc.Devices08/10/2023DHR - not or inadequately maintained
Surgitech, Inc.Devices08/10/2023Complaints
Tandem Diabetes Care, Inc.Devices03/23/2023Lack of or inadequate procedures
Trade Rooster, Inc.Food and Cosmetics08/31/2023Develop FSVP
Trade Rooster, Inc.Food and Cosmetics08/31/2023Supplier approval - document
Trade Rooster, Inc.Food and Cosmetics08/31/2023Verification activity - appropriate
Trade Rooster, Inc.Food and Cosmetics08/31/2023Verification activity before import, periodically
True Function Laboratory, Inc.Devices08/07/2023Management review - Lack of or inadequate procedures
True Function Laboratory, Inc.Devices08/07/2023Calibration, Inspection, etc. Procedures Lack of or Inadequ
True Function Laboratory, Inc.Devices08/07/2023Lack of or inadequate procedures - Acceptance activities
True Function Laboratory, Inc.Devices08/07/2023Nonconforming product, Lack of or inadequate procedures
True Function Laboratory, Inc.Devices08/07/2023Documentation
True Function Laboratory, Inc.Devices08/07/2023Lack of or inadequate DHR procedures
True Function Laboratory, Inc.Devices08/07/2023Review and evaluation for investigation
VidasoyFood and Cosmetics03/30/2023Sanitary operations - Plant maintenance
VidasoyFood and Cosmetics03/30/2023Pest control
VidasoyFood and Cosmetics03/30/2023Manufacturing, processing, packing, holding - Controls
VidasoyFood and Cosmetics03/30/2023Procedural requirements
Vmaco, Inc.Food and Cosmetics06/08/2023Develop FSVP
Zuland Distributor, CORPFood and Cosmetics09/28/2023Develop FSVP
Zuland Distributor, CORPFood and Cosmetics09/28/2023Verification activity - appropriate
Zuland Distributor, CORPFood and Cosmetics09/28/2023Verification activity before import, periodically
Zuland Distributor, CORPFood and Cosmetics09/28/2023Audit - food safety regulation, plan

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