Central OC Times

There were 15 companies in cities associated with Orange County that received FDA citations as a result of 15 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 34.8% decrease from the number of companies cited in the previous quarter.

Of the 38 citations issued, the most common citation was 'You did not take a reasonable measure or precaution related to personnel practices'.

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, 13 should take voluntary actions to correct their managing operations (86.7%). Additionally, one company had to take regulatory and/or administrative actions (6.7%).

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
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
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
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
Interfresh, Inc.	Food and Cosmetics	10/23/2023	Evaluation - performance, risk
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
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
Nina Mia, Inc.	Food and Cosmetics	10/16/2023	Critical control points
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
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
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
Wisetrade Corporation	Food and Cosmetics	12/06/2023	Record - available
Wisetrade Corporation	Food and Cosmetics	12/06/2023	Record - translate to English