West OC Times

There were 67 companies in cities associated with Orange County that received FDA citations as a result of 70 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 76.3% increase over the number of companies cited in the previous year.

Of the 193 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 Biologics sector.

Of the companies cited, 60 should take voluntary actions to correct their managing operations (89.6%). Additionally, seven companies had to take regulatory and/or administrative actions (10.4%).

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
Alumni Partners	Food and Cosmetics	03/08/2023	Sanitary operations - Plant maintenance
Alumni Partners	Food and Cosmetics	03/08/2023	Sanitary operations - Plant sanitation
Alumni Partners	Food and Cosmetics	03/08/2023	Equipment and utensils - Design and maintenance
Ari's Wholesale, LLC	Food and Cosmetics	08/09/2023	Develop FSVP
Asahi Intecc Usa, Inc.	Devices	06/01/2023	Design validation- Lack of or inadequate procedures
Asahi Intecc Usa, Inc.	Devices	06/01/2023	Lack of or inadequate complaint procedures
B. Braun Medical, Inc.	Drugs	12/15/2023	Sampling and testing plans not followed
B. Braun Medical, Inc.	Drugs	12/15/2023	Representative Number of Batches for Annual Review
B. Braun Medical, Inc.	Drugs	12/15/2023	Investigations of discrepancies, failures
Balance Factor, Inc.	Food and Cosmetics	06/06/2023	Written procedures - quality control operations
Balance Factor, Inc.	Food and Cosmetics	06/06/2023	Written procedures - holding
Balance Factor, Inc.	Food and Cosmetics	06/06/2023	Written procedures - returned dietary supplement
Balance Factor, Inc.	Food and Cosmetics	06/06/2023	Written procedures - product complaint
Balt USA, LLC	Devices	07/21/2023	Individual Report of Malfunction
Balt USA, LLC	Devices	07/21/2023	Acceptance status
Balt USA, LLC	Devices	07/21/2023	Documentation
Barohup, Inc.	Food and Cosmetics	08/21/2023	Hazard analysis written
Barohup, Inc.	Food and Cosmetics	08/21/2023	Evaluation - performance, risk
Barohup, Inc.	Food and Cosmetics	08/21/2023	Supplier approval - document
Barohup, Inc.	Food and Cosmetics	08/21/2023	Continue to import, change activities
Barohup, Inc.	Food and Cosmetics	08/21/2023	Onsite audit
Barohup, Inc.	Food and Cosmetics	08/21/2023	Verification activity before import, periodically
Boba Boyz, LLC	Food and Cosmetics	04/11/2023	Develop FSVP
Bread Artisan Bakery, Inc.	Food and Cosmetics	08/18/2023	Personnel
Bread Artisan Bakery, Inc.	Food and Cosmetics	08/18/2023	Equipment and utensils - Design and maintenance
Bread Artisan Bakery, Inc.	Food and Cosmetics	08/18/2023	Manufacturing, processing, packing, holding - Controls
CJ Foods Manufacturing Corporation	Food and Cosmetics	02/23/2023	Sanitation preventive controls - Appropriate (Adequate)
Citro Fresh, LLC	Food and Cosmetics	08/28/2023	Develop FSVP
Citro Fresh, LLC	Food and Cosmetics	08/28/2023	Evaluation - performance, risk
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Procedures not in writing, fully followed
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Equipment Design, Size and Location
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Establish reliability of supplier's C of A
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Absence of Written Procedures
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Acceptance criteria for sampling & testing
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Valid stability test methods
Clinical Resolution Laboratory, Inc.	Drugs	09/29/2023	Investigations of discrepancies, failures
Cognita Labs, LLC	Devices	12/13/2023	Procedures for product review,disposition lack of/inadequate
Cognita Labs, LLC	Devices	12/13/2023	Lack of or inadequate DHR procedures
Cookie Jar Collection, Inc.	Food and Cosmetics	10/06/2023	Manufacturing, processing, packing, holding - Controls
DS Services of America, Inc.	Food and Cosmetics	06/01/2023	Storage and Distribution
DS Services of America, Inc.	Food and Cosmetics	06/01/2023	Supply-chain program - Records
DS Services of America, Inc.	Food and Cosmetics	06/01/2023	Non-sealed system
Dang Vu, Inc.	Food and Cosmetics	07/06/2023	Personnel
Dang Vu, Inc.	Food and Cosmetics	07/06/2023	Sanitary operations - Plant maintenance
Dang Vu, Inc.	Food and Cosmetics	07/06/2023	Sanitation of food-contact surfaces - Frequency
Dang Vu, Inc.	Food and Cosmetics	07/06/2023	Sanitation of non-food-contact surfaces - Manner and frequency
Dang Vu, Inc.	Food and Cosmetics	07/06/2023	Sanitary facilities and controls
Dang Vu, Inc.	Food and Cosmetics	07/06/2023	Manufacturing, processing, packing, holding - Controls
Dendreon Pharmaceuticals, LLC	Biologics	08/10/2023	Rejecting When Specifications Not Met
Dendreon Pharmaceuticals, LLC	Biologics	08/10/2023	Extent of discrepancy, failure investigations
Dkb Household Usa	Food and Cosmetics	04/11/2023	Develop FSVP
Elite BioFusion, LLC	Biologics	09/29/2023	Procedures for complaints and other information
Elite BioFusion, LLC	Biologics	09/29/2023	Procedures and release criteria
Elite BioFusion, LLC	Biologics	09/29/2023	Prompt retrieval from multiple locations
Envita Fertility Center	Biologics	10/06/2023	Review and approval of procedures
Envita Fertility Center	Biologics	10/06/2023	Name and personal info on accompanying records
Fertility Center of Orange County, A Medical Group, Inc.	Biologics	08/29/2023	Responsible person to determine, document
Fertility Center of Orange County, A Medical Group, Inc.	Biologics	08/29/2023	Documentation--determination, by whom, date
Fertility Center of Orange County, A Medical Group, Inc.	Biologics	08/29/2023	Accurate, indelible, legible
First Biotech, Inc.	Food and Cosmetics	09/14/2023	Develop FSVP
Genesis Biologics, Inc.	Biologics	07/21/2023	Procedures for cleaning, sanitation
Greenfruit Avocados, LLC	Food and Cosmetics	06/06/2023	Evaluation - performance, risk
Greenfruit Avocados, LLC	Food and Cosmetics	06/06/2023	Audit - food safety regulation, plan
HCN Industries, Inc.	Food and Cosmetics	08/16/2023	Reserve sample - collect, hold
HCN Industries, Inc.	Food and Cosmetics	08/16/2023	Quality control - supplier qualification
HCN Industries, Inc.	Food and Cosmetics	08/16/2023	Quality control monitoring; production, process control system
Have'a Natural Foods, Inc.	Food and Cosmetics	01/13/2023	Raw materials and rework controls - Filth and contamination
Have'a Natural Foods, Inc.	Food and Cosmetics	01/13/2023	Food safety plan
Have'a Natural Foods, Inc.	Food and Cosmetics	01/13/2023	PCQI training records
Huntington Reproductive Center Medical Group	Biologics	03/28/2023	Determination based on screening and testing
Huntington Reproductive Center Medical Group	Biologics	03/28/2023	Name and personal info on accompanying records
Interfresh, Inc.	Food and Cosmetics	10/23/2023	Evaluation - performance, risk
KB Transpacific Trading, LLC	Food and Cosmetics	06/06/2023	Develop FSVP
Kat & ELL, Corp.	Food and Cosmetics	02/21/2023	Develop FSVP
L & R Fine Food, Inc.	Food and Cosmetics	06/28/2023	Critical control points
L & R Fine Food, Inc.	Food and Cosmetics	06/28/2023	Critical limits
L & R Fine Food, Inc.	Food and Cosmetics	06/28/2023	Monitoring - adequacy
La Cabana Food Distributor	Food and Cosmetics	10/12/2023	Personnel
La Cabana Food Distributor	Food and Cosmetics	10/12/2023	Sanitation of food-contact surfaces - Frequency
Links Medical Products, Inc.	Devices	10/18/2023	Lack of or inadequate procedures
MSJ Foods, Inc.	Food and Cosmetics	11/15/2023	Personnel
MSJ Foods, Inc.	Food and Cosmetics	11/15/2023	Sanitary operations - Plant sanitation
MSJ Foods, Inc.	Food and Cosmetics	11/15/2023	Pest control
MSJ Foods, Inc.	Food and Cosmetics	11/15/2023	Equipment and utensils - Design and maintenance
Marukome USA, Inc.	Food and Cosmetics	08/08/2023	Sanitary operations - Plant maintenance
Marukome USA, Inc.	Food and Cosmetics	08/08/2023	Pest control
Marukome USA, Inc.	Food and Cosmetics	08/08/2023	Sanitary facilities and controls
Medsource Pharmaceuticals	Drugs	12/11/2023	Equipment Design, Size and Location
Medsource Pharmaceuticals	Drugs	12/11/2023	Cleaning / Sanitizing / Maintenance
Medsource Pharmaceuticals	Drugs	12/11/2023	Changes to Procedures Not Reviewed, Approved
Medsource Pharmaceuticals	Drugs	12/11/2023	Storage under appropriate conditions
Mettler Electronics Corporation	Devices	09/14/2023	Training records
Mettler Electronics Corporation	Devices	09/14/2023	Purchasing controls, Lack of or inadequate procedures
Mettler Electronics Corporation	Devices	09/14/2023	Acceptable supplier records, inadequate records
Mettler Electronics Corporation	Devices	09/14/2023	Production and Process Change Procedures, lack of or Inad.
Microvention, Inc.	Devices	05/04/2023	Design validation - user needs and intended uses
Minh Phung, Inc.	Food and Cosmetics	05/04/2023	Personnel
Minh Phung, Inc.	Food and Cosmetics	05/04/2023	Sanitary operations - Plant maintenance
Minh Phung, Inc.	Food and Cosmetics	05/04/2023	Sanitary operations - Plant sanitation
Minh Phung, Inc.	Food and Cosmetics	05/04/2023	Equipment and utensils - Design and maintenance
Minh Phung, Inc.	Food and Cosmetics	05/04/2023	Manufacturing, processing, packing, holding - Controls
Minh Phung, Inc.	Food and Cosmetics	05/04/2023	Storage and Distribution
Minhs Meat Company, Inc.	Food and Cosmetics	01/05/2023	Personnel
Minhs Meat Company, Inc.	Food and Cosmetics	01/05/2023	Plant construction and design
Neurotris, Inc.	Devices	04/25/2023	Design changes - Lack of or Inadequate Procedures
Neurotris, Inc.	Devices	04/25/2023	Purchasing controls, Lack of or inadequate procedures
Neurotris, Inc.	Devices	04/25/2023	Nonconforming product, Lack of or inadequate procedures
Neurotris, Inc.	Devices	04/25/2023	Lack of or inadequate procedures
New Health Products, Inc.	Food and Cosmetics	02/08/2023	Develop FSVP
Nina Mia, Inc.	Food and Cosmetics	10/16/2023	Critical control points
Nutrawise Health & Beauty, LLC	Food and Cosmetics	03/23/2023	Specifications - component identity
Nutrawise Health & Beauty, LLC	Food and Cosmetics	03/23/2023	Quality control - processes, specifications, written procedures
OC Snacks Sweets & Treats	Food and Cosmetics	12/06/2023	Sanitation of food-contact surfaces - Frequency
OC Snacks Sweets & Treats	Food and Cosmetics	12/06/2023	Sanitation of non-food-contact surfaces - Manner and frequency
OC Snacks Sweets & Treats	Food and Cosmetics	12/06/2023	Equipment and utensils - Design and maintenance
OC Snacks Sweets & Treats	Food and Cosmetics	12/06/2023	Storage and Distribution
Old Fashioned Natural Products, Inc.	Food and Cosmetics	08/17/2023	Specifications - identity, purity, strength, composition
Old Fashioned Natural Products, Inc.	Food and Cosmetics	08/17/2023	Written procedures - holding
Old Fashioned Natural Products, Inc.	Food and Cosmetics	08/17/2023	Quality control - processes, specifications, written procedures
Ondal Kimchi, Inc.	Food and Cosmetics	05/12/2023	Develop FSVP
Orange Lab, Inc.	Drugs	09/21/2023	Electronic records
Orange Lab, Inc.	Drugs	09/21/2023	Procedures not in writing, fully followed
Orange Lab, Inc.	Drugs	09/21/2023	Equipment Design, Size and Location
Orange Lab, Inc.	Drugs	09/21/2023	Written procedures not established/followed
Orange Lab, Inc.	Drugs	09/21/2023	Identity Testing of Each Component
Orange Lab, Inc.	Drugs	09/21/2023	Testing Each Component for Conformity with Specs
Orange Lab, Inc.	Drugs	09/21/2023	Absence of Written Procedures
Orange Lab, Inc.	Drugs	09/21/2023	Labeling and packaging improperly approved/released
Orange Lab, Inc.	Drugs	09/21/2023	Scientifically sound laboratory controls
Pacific Reproductive Center, Inc.	Biologics	08/31/2023	Determination based on screening and testing
Packaging On Demand, Inc.	Drugs	01/13/2023	Equipment Design, Size and Location
Packaging On Demand, Inc.	Drugs	01/13/2023	Computer control of master formula records
Packaging On Demand, Inc.	Drugs	01/13/2023	Reports of Analysis (Components)
Packaging On Demand, Inc.	Drugs	01/13/2023	Rejecting When Specifications Not Met
Packaging On Demand, Inc.	Drugs	01/13/2023	Absence of Written Procedures
Packaging On Demand, Inc.	Drugs	01/13/2023	Written program not followed
Packaging On Demand, Inc.	Drugs	01/13/2023	Annual visual exams of drug products
Packaging On Demand, Inc.	Drugs	01/13/2023	Items to cover on annual reviews
Packaging On Demand, Inc.	Drugs	01/13/2023	Quality control unit review of records
Performance Research Laboratories, Inc.	Food and Cosmetics	08/17/2023	Written procedures - holding
Productos Mole Rojo Victoria USA	Food and Cosmetics	02/08/2023	Develop FSVP
STIR Foods, LLC	Food and Cosmetics	07/20/2023	Monitoring - adequacy
STPCA, Inc.	Food and Cosmetics	11/20/2023	Specifications - component identity
STPCA, Inc.	Food and Cosmetics	11/20/2023	Specifications-component purity, strength, composition
STPCA, Inc.	Food and Cosmetics	11/20/2023	Specifications - identity, purity, strength, composition
STPCA, Inc.	Food and Cosmetics	11/20/2023	Appropriate tests, examinations; certificate of analysis
STPCA, Inc.	Food and Cosmetics	11/20/2023	Specifications met - verify; finished batch
STPCA, Inc.	Food and Cosmetics	11/20/2023	Quality control - production, process control
STPCA, Inc.	Food and Cosmetics	11/20/2023	Master manufacturing record - controls, procedures
Sanitor Corporation	Drugs	04/14/2023	Procedures not in writing, fully followed
Sanitor Corporation	Drugs	04/14/2023	Training--operations, GMPs, written procedures
Sanitor Corporation	Drugs	04/14/2023	Equipment for Environmental Control
Sanitor Corporation	Drugs	04/14/2023	Computer control of master formula records
Sanitor Corporation	Drugs	04/14/2023	Results not used for expiration dates, storage cond.
Southern California Center for Reproductive Medicine	Biologics	12/13/2023	Determination based on screening and testing
Southern California Center for Reproductive Medicine	Biologics	12/13/2023	Completion of eligibility determination
Southern California Center for Reproductive Medicine	Biologics	12/13/2023	Eligibility not required--warning labels
Southern California Center for Reproductive Medicine	Biologics	01/20/2023	Testing, screening, donor eligibility procedures
Southern California Center for Reproductive Medicine	Biologics	01/20/2023	Name and personal info on accompanying records
Southern California Center for Reproductive Medicine	Biologics	01/20/2023	Risk factors, clinical evidence
Sperm Bank, Inc.	Biologics	09/29/2023	Statement re: certified testing lab
Sperm Bank, Inc.	Biologics	09/29/2023	Name and address on summary
Sperm Bank, Inc.	Biologics	09/29/2023	Risk factors, clinical evidence
Synovo Production	Devices	10/02/2023	Training records
Synovo Production	Devices	10/02/2023	Design history file
Synovo Production	Devices	10/02/2023	Evaluation and Selection, Suppliers, Contractors, etc.
Synovo Production	Devices	10/02/2023	Documentation
Synovo Production	Devices	10/02/2023	Documentation
Tan Hoang Huong Distribution, LLC	Food and Cosmetics	12/13/2023	Personnel
Tan Hoang Huong Distribution, LLC	Food and Cosmetics	12/13/2023	Sanitary operations - Plant sanitation
Tan Hoang Huong Distribution, LLC	Food and Cosmetics	12/13/2023	Sanitation of food-contact surfaces - Frequency
Tox Laboratory, M.D.	Biologics	07/20/2023	Manufacturer instructions not followed
Tox Laboratory, M.D.	Biologics	07/20/2023	All core requirements covered in program
Tox Laboratory, M.D.	Biologics	07/20/2023	Computer software verification
Tox Laboratory, M.D.	Biologics	07/20/2023	Procedures to meet core CTGP
Tox Laboratory, M.D.	Biologics	07/20/2023	Size, construction, location--prevent mix-ups etc.
Tox Laboratory, M.D.	Biologics	07/20/2023	Records incomplete
Tox Laboratory, M.D.	Biologics	07/20/2023	Retention time (10 year rules)
Transfer Technology, Inc.	Drugs	04/28/2023	Procedures not in writing, fully followed
Trong Food International	Food and Cosmetics	04/11/2023	Food safety plan
Trong Food International	Food and Cosmetics	03/23/2023	Sanitation of food-contact surfaces - Frequency
Trong Food International	Food and Cosmetics	03/23/2023	Equipment and utensils - Design and maintenance
Vanlaw Food Products, Inc.	Food and Cosmetics	09/19/2023	Manufacturing, processing, packing, holding - Controls
Vanlaw Food Products, Inc.	Food and Cosmetics	09/19/2023	No HACCP plan
Visvita Corporation	Food and Cosmetics	05/25/2023	Develop FSVP
Visvita Corporation	Food and Cosmetics	05/25/2023	Review entity's hazard analysis
Visvita Corporation	Food and Cosmetics	05/25/2023	Verification activity review, assess
West Coast Fertility Centers, LLC	Biologics	06/05/2023	Testing, screening, donor eligibility procedures
West Coast Fertility Centers, LLC	Biologics	06/05/2023	Risk factors, clinical evidence
Westridge Laboratories, Inc.	Devices	01/18/2023	Rationale documented for no investigation
Wisetrade Corporation	Food and Cosmetics	02/15/2023	Develop FSVP
Wisetrade Corporation	Food and Cosmetics	12/06/2023	Record - available
Wisetrade Corporation	Food and Cosmetics	12/06/2023	Record - translate to English