SE LA Times

There were 53 companies in cities associated with Los Angeles County that received FDA citations as a result of 53 inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 51.4% increase over the number of companies cited in the previous quarter.

Of the 155 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 .

Of the companies cited, 45 should take voluntary actions to correct their managing operations (84.9%). Additionally, seven companies had to take regulatory and/or administrative actions (13.2%).

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
A Plus Vegetable, Inc.	Food and Cosmetics	11/08/2023	Develop FSVP
AKT Trading, Inc.	Food and Cosmetics	12/15/2023	Continue to import, change activities
AKT Trading, Inc.	Food and Cosmetics	12/15/2023	Revaluate - new information
AKT Trading, Inc.	Food and Cosmetics	12/15/2023	Supplier verification assurance
AKT Trading, Inc.	Food and Cosmetics	12/15/2023	Investigate
America Fruits, LLC	Food and Cosmetics	12/06/2023	Document review entity's hazard analysis
America Fruits, LLC	Food and Cosmetics	12/06/2023	Evaluation - performance, risk
America Fruits, LLC	Food and Cosmetics	12/06/2023	Approved supplier procedures - importer established
America Fruits, LLC	Food and Cosmetics	12/06/2023	Verification activity before import, periodically
America Fruits, LLC	Food and Cosmetics	12/06/2023	Verification activity review, assess
Bimbo Bakeries USA, Inc.	Food and Cosmetics	10/13/2023	Plant construction and design
Bimbo Bakeries USA, Inc.	Food and Cosmetics	10/13/2023	Sanitary operations - Plant sanitation
Bimbo Bakeries USA, Inc.	Food and Cosmetics	10/13/2023	Process preventive controls - Implement
Blaine Labs, Inc.	Drugs	12/15/2023	Procedures not in writing, fully followed
Blaine Labs, Inc.	Drugs	12/15/2023	Equipment Design, Size and Location
Blaine Labs, Inc.	Drugs	12/15/2023	Control procedures to monitor and validate performance
Blaine Labs, Inc.	Drugs	12/15/2023	Storage under appropriate conditions
C. A. R. E. Fertility	Biologics	10/26/2023	Testing, screening, donor eligibility procedures
C. A. R. E. Fertility	Biologics	10/26/2023	Name and personal info on accompanying records
C. A. R. E. Fertility	Biologics	10/26/2023	Ten year retention
C. A. R. E. Fertility	Biologics	10/26/2023	Completion of eligibility determination
C. A. R. E. Fertility	Biologics	10/26/2023	Risk factors, clinical evidence
C. A. R. E. Fertility	Biologics	10/26/2023	Eligibility not required--warning labels
Cconma, Inc.	Food and Cosmetics	10/17/2023	Hazard analysis biological, chemical, physical
Cconma, Inc.	Food and Cosmetics	10/17/2023	Document review entity's hazard analysis
Cconma, Inc.	Food and Cosmetics	10/17/2023	Evaluation - performance, risk
Cconma, Inc.	Food and Cosmetics	10/17/2023	Supplier approval - document
Cconma, Inc.	Food and Cosmetics	10/17/2023	Verification activity frequency
DSP Skin Care, LLC	Drugs	10/12/2023	Approve or reject procedures or specs
DSP Skin Care, LLC	Drugs	10/12/2023	Procedures are written, and followed
DSP Skin Care, LLC	Drugs	10/12/2023	Written distribution procedure
DSP Skin Care, LLC	Drugs	10/12/2023	Testing and release for distribution
DSP Skin Care, LLC	Drugs	10/12/2023	Lack of written stability program
Dae Won Food USA, Inc.	Food and Cosmetics	11/14/2023	Personnel
Dae Won Food USA, Inc.	Food and Cosmetics	11/14/2023	Sanitation of food-contact surfaces - Frequency
Daniel Norman, M.D.	Drugs	10/17/2023	Case history records- inadequate or inadequate
Dole Packaged Foods, LLC	Food and Cosmetics	12/12/2023	Audit - food safety regulation, plan
Dole Packaged Foods, LLC	Food and Cosmetics	12/12/2023	Identification - entry
El Cerdito	Food and Cosmetics	10/25/2023	Develop FSVP
El Cerdito	Food and Cosmetics	10/25/2023	Identification - entry
FIJI Water Company, LLC	Food and Cosmetics	11/13/2023	Document review entity's hazard analysis
Felbro Food Products	Food and Cosmetics	10/18/2023	Process filing
Fervasi, Inc.	Food and Cosmetics	11/29/2023	Develop FSVP
Fervasi, Inc.	Food and Cosmetics	11/29/2023	Identification - entry
Foremost Foods International, Inc.	Food and Cosmetics	12/11/2023	Importer verification
Fresh Pic, Inc.	Food and Cosmetics	11/13/2023	Develop FSVP
G & B Wholesale Foods, Inc.	Food and Cosmetics	10/20/2023	Sanitary operations - Plant maintenance
G & B Wholesale Foods, Inc.	Food and Cosmetics	10/20/2023	Storage and Distribution
Golden Beach, Inc.	Food and Cosmetics	11/21/2023	Verification activity before import, periodically
Health Specialty	Drugs	11/30/2023	Procedures not in writing, fully followed
Health Specialty	Drugs	11/30/2023	Training--operations, GMPs, written procedures
Health Specialty	Drugs	11/30/2023	Equipment Design, Size and Location
Health Specialty	Drugs	11/30/2023	Absence of Written Procedures
Health Specialty	Drugs	11/30/2023	Test methods
Health Specialty	Drugs	11/30/2023	Results not used for expiration dates, storage cond.
Huntington Reproductive Center Medical Group	Biologics	11/06/2023	Determination based on screening and testing
Huntington Reproductive Center Medical Group	Biologics	11/06/2023	Completion of eligibility determination
Huntington Reproductive Center Medical Group	Biologics	11/06/2023	Eligibility not required--warning labels
Innovation Specialties, Inc.	Drugs	12/08/2023	Procedures not in writing, fully followed
KJC America, Inc.	Food and Cosmetics	11/03/2023	Hazard analysis biological, chemical, physical
KJC America, Inc.	Food and Cosmetics	11/03/2023	Supplier verification assurance
KJC America, Inc.	Food and Cosmetics	11/03/2023	Sampling, testing
Kim-Seng Company	Food and Cosmetics	11/02/2023	Develop FSVP
Kim-Seng Company	Food and Cosmetics	11/02/2023	Hazard analysis biological, chemical, physical
Kim-Seng Company	Food and Cosmetics	11/02/2023	Evaluation - performance, risk
Kim-Seng Company	Food and Cosmetics	11/02/2023	Supplier verification - establish written procedures
Kim-Seng Company	Food and Cosmetics	11/02/2023	Verification activity assurance
Kim-Seng Company	Food and Cosmetics	11/02/2023	Verification activity before import, periodically
L&C Food Depot	Food and Cosmetics	12/18/2023	Develop FSVP
LA Esperanza Produce, Inc.	Food and Cosmetics	11/07/2023	Not registered
LA Esperanza Produce, Inc.	Food and Cosmetics	11/07/2023	Develop FSVP
LA Esperanza Produce, Inc.	Food and Cosmetics	11/07/2023	Evaluation - performance, risk
LMS Distriburors, LLC	Food and Cosmetics	10/24/2023	Develop FSVP
La Frontera	Food and Cosmetics	10/26/2023	Equipment and utensils - Design and maintenance
La Sucursal Produce, Inc.	Food and Cosmetics	10/25/2023	Not registered
La Sucursal Produce, Inc.	Food and Cosmetics	10/25/2023	Develop FSVP
La Sucursal Produce, Inc.	Food and Cosmetics	10/25/2023	Evaluation - performance, risk
MGH Gourmet, Inc.	Food and Cosmetics	10/23/2023	Sanitation preventive controls - Appropriate (Adequate)
Modern Foods Corporation	Food and Cosmetics	10/05/2023	Develop FSVP
Mrs. Williams Country Kitchen, Inc.	Food and Cosmetics	12/08/2023	Manufacturing, processing, packing, holding - Controls
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Evaluation - performance, risk
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Supplier verification - follow written procedures
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Supplier verification assurance
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Onsite audit
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Audit - food safety regulation, plan
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Record - sign, date
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Record - available
Nonghyup America, Inc.	Food and Cosmetics	12/22/2023	Record - translate to English
Norman, Fox And Company	Drugs	11/03/2023	Component identification test
Norman, Fox And Company	Drugs	11/03/2023	Scientifically sound laboratory controls
Norman, Fox And Company	Drugs	11/03/2023	Record maintenance 1 year (except exempt OTC)
Norman, Fox And Company	Drugs	11/03/2023	Records reviewed annually
Ocean Group, Inc.	Food and Cosmetics	12/21/2023	Sanitation monitoring
Ocean Group, Inc.	Food and Cosmetics	12/21/2023	Importer verification
Ocean King Fish, Inc.	Food and Cosmetics	12/15/2023	HACCP plan implementation
Ortho Precision Products	Devices	11/14/2023	DHR - not or inadequately maintained
Osi Optoelectronics, Inc.	Devices	10/18/2023	Design validation - documentation
Pacific Crayfish Company	Food and Cosmetics	10/26/2023	HACCP plan implementation
Pacific Crayfish Company	Food and Cosmetics	10/26/2023	No HACCP plan
Pacific Crayfish Company	Food and Cosmetics	10/26/2023	Verification procedures - adequacy
Pacific Crayfish Company	Food and Cosmetics	10/26/2023	Signed and dated
Pacific Crayfish Company	Food and Cosmetics	10/26/2023	Reassessment of HACCP plan
Pacific Giant, Inc.	Food and Cosmetics	10/16/2023	Develop FSVP
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Training for supervisors
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Hygienic practices
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Food contact surface sanitary inspection and maintenance
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Environmental testing requirements
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Testing spent irrigation water
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Written environmental monitoring plan
Pear Garden Produce, LLC	Food and Cosmetics	10/13/2023	Written sampling plan for spent irrigation water or sprouts
Produce Pay, Inc.	Food and Cosmetics	12/04/2023	Evaluation - performance, risk
Produce Pay, Inc.	Food and Cosmetics	12/04/2023	Supplier approval - document
Produce Pay, Inc.	Food and Cosmetics	12/04/2023	Verification activity frequency
Produce Pay, Inc.	Food and Cosmetics	12/04/2023	Verification activity before import, periodically
Promate Produce USA	Food and Cosmetics	12/15/2023	Develop FSVP
Promate Produce USA	Food and Cosmetics	12/15/2023	Supplier approval - document
Promate Produce USA	Food and Cosmetics	12/15/2023	Supplier verification - establish written procedures
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Personnel
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Sanitary operations - Plant maintenance
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Sanitary operations - Plant sanitation
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Cleaning and sanitizing substances - Safe and adequate
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Pest control
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Equipment and utensils - Design and maintenance
Red Shell Foods, Inc.	Food and Cosmetics	12/12/2023	Manufacturing, processing, packing, holding - Controls
Redox, Inc.	Food and Cosmetics	11/20/2023	Develop FSVP
Redox, Inc.	Food and Cosmetics	11/20/2023	Hazard analysis biological, chemical, physical
Redox, Inc.	Food and Cosmetics	11/20/2023	Evaluation - performance, risk
Redox, Inc.	Food and Cosmetics	11/20/2023	Approved supplier procedures - importer established
Redox, Inc.	Food and Cosmetics	11/20/2023	Verification activity assurance
Signeture, Corp.	Food and Cosmetics	10/26/2023	Very small importer assurances, supplier
Specialty Company Pack, Inc.	Food and Cosmetics	12/11/2023	Develop FSVP
The Hain Celestial	Drugs	10/20/2023	Control procedures to monitor and validate performance
The Hain Celestial	Drugs	10/20/2023	Investigations of discrepancies, failures
Tres Marias Produce, LLC	Food and Cosmetics	10/04/2023	Develop FSVP
Treto'S, Inc.	Food and Cosmetics	12/07/2023	Hazard analysis written
Treto'S, Inc.	Food and Cosmetics	12/07/2023	Evaluation - performance, risk
Treto'S, Inc.	Food and Cosmetics	12/07/2023	Approved supplier procedures - importer established
Two Lucky Star, Inc.	Food and Cosmetics	10/25/2023	Develop FSVP
Unistar Foods, Inc.	Food and Cosmetics	11/06/2023	Modified requirement: Temperature control - Implement
Unistar Foods, Inc.	Food and Cosmetics	11/06/2023	HACCP training or qualification
Unistar Foods, Inc.	Food and Cosmetics	11/06/2023	Importer verification
Westwood Laboratories, LLC.	Drugs	11/20/2023	Authority lacking to review records, investigate errors
Westwood Laboratories, LLC.	Drugs	11/20/2023	Training , Education , Experience overall
Westwood Laboratories, LLC.	Drugs	11/20/2023	Equipment Design, Size and Location
Westwood Laboratories, LLC.	Drugs	11/20/2023	Identity Testing of Each Component
Westwood Laboratories, LLC.	Drugs	11/20/2023	Scientifically sound laboratory controls
Westwood Laboratories, LLC.	Drugs	11/20/2023	Lack of written stability program
Westwood Laboratories, LLC.	Drugs	11/20/2023	Records reviewed annually
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Authority lacking to review records, investigate errors
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Training , Education , Experience overall
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Equipment Design, Size and Location
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Identity Testing of Each Component
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Scientifically sound laboratory controls
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Lack of written stability program
Westwood Laboratories, LLC.	Veterinary	11/20/2023	Records reviewed annually