South Broward News

There were 32 companies in cities associated with Broward County that received FDA citations as a result of 32 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 20% decrease from the number of companies cited in the previous year.

Of the 107 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, 31 should take voluntary actions to correct their managing operations (96.9%). Additionally, one company had to take regulatory and/or administrative actions (3.1%).

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
AVEVA Drug Delivery Systems, Inc.	Drugs	09/01/2023	Washing and toilet facilities are deficient
AVEVA Drug Delivery Systems, Inc.	Drugs	09/01/2023	Label storage access limited to authorized personnel
Arcadlab, LLC	Devices	09/01/2023	Management review dates
Arcadlab, LLC	Devices	09/01/2023	Design control - no procedures
Arcadlab, LLC	Devices	09/01/2023	Lack of or inadequate DHR procedures
Associated Grocers of Florida, Inc.	Food and Cosmetics	08/29/2023	Plant construction and design
Associated Grocers of Florida, Inc.	Food and Cosmetics	08/29/2023	Pest control
Associated Grocers of Florida, Inc.	Food and Cosmetics	08/29/2023	Manufacturing, processing, packing, holding - Controls
Bake123, LLC	Food and Cosmetics	04/26/2023	Develop FSVP
Beth E. Safirstein, M.D.	Biologics	06/05/2023	FD-1572, protocol compliance
Cambridge Diagnostic Products, Inc.	Devices	03/16/2023	Lack of System for Timely Submission of Reports
Cambridge Diagnostic Products, Inc.	Devices	03/16/2023	Quality audits - Lack of or inadequate procedures
Cambridge Diagnostic Products, Inc.	Devices	03/16/2023	Acceptable supplier records, inadequate records
Cambridge Diagnostic Products, Inc.	Devices	03/16/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cambridge Diagnostic Products, Inc.	Devices	03/16/2023	Lack of or inadequate complaint procedures
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Develop FSVP
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Hazard analysis biological, chemical, physical
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Evaluation - performance, risk
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Approved supplier procedures - importer established
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Verification activity assurance
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Verification activity frequency
Caribbean Link USA, Inc.	Food and Cosmetics	05/26/2023	Verification activity before import, periodically
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Production, process controls - packaged, labeled
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Written procedures - holding; distributing
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Records - returned dietary supplement: written procedures
Classical Insights, LLC	Food and Cosmetics	01/24/2023	Sanitation of food-contact surfaces - Frequency
Curonix, LLC	Devices	11/08/2023	Software validation for automated processes
Curonix, LLC	Devices	11/08/2023	Procedures for product review,disposition lack of/inadequate
Curonix, LLC	Devices	11/08/2023	Lack of or inadequate procedures
Curonix, LLC	Devices	11/08/2023	Lack of or inadequate complaint procedures
ECI Pharmaceuticals, LLC	Drugs	01/27/2023	Failure to develop written procedures
ECI Pharmaceuticals, LLC	Drugs	01/27/2023	Late submission of annual safety reports
ECI Pharmaceuticals, LLC	Drugs	01/27/2023	Failure to maintain records
ECI Pharmaceuticals, LLC	Drugs	01/27/2023	Timely submission
EOSolutions, Corp.	Devices	12/07/2023	Quality audits - Lack of or inadequate procedures
EOSolutions, Corp.	Devices	12/07/2023	Training - Lack of or inadequate procedures
Fettech	Devices	07/14/2023	Quality audits - auditor independence
Finish Line Feeds, Inc.	Veterinary	09/08/2023	Develop FSVP
First World Imports, Inc.	Food and Cosmetics	03/28/2023	Develop FSVP
Franco's Cocktail Products, Inc.	Food and Cosmetics	09/11/2023	Hazard analysis - Identification of hazard
Franco's Cocktail Products, Inc.	Food and Cosmetics	09/11/2023	Allergen preventive controls - Identify (Written)
GA Food Service of Pinellas County, LLC.	Food and Cosmetics	02/13/2023	Plant construction and design
GA Food Service of Pinellas County, LLC.	Food and Cosmetics	02/13/2023	Manufacturing, processing, packing, holding - Controls
GTO Import Export, LLC	Food and Cosmetics	03/01/2023	Develop FSVP
Gourmet Salads & Pickles, Inc.	Food and Cosmetics	09/25/2023	Signed and dated
Mena Food Group, LLC.	Food and Cosmetics	11/20/2023	Personnel
Mena Food Group, LLC.	Food and Cosmetics	11/20/2023	Sanitary operations - Plant maintenance
Mena Food Group, LLC.	Food and Cosmetics	11/20/2023	Hazard analysis - Identification of hazard
Mena Food Group, LLC.	Food and Cosmetics	11/20/2023	Allergen preventive controls - Implement
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Justification for not reporting
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Design input - documentation
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Design changes - Lack of or Inadequate Procedures
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Purchasing controls, Lack of or inadequate procedures
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Nonconforming product, Lack of or inadequate procedures
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Lack of or inadequate procedures
New Wave Endo-Surgical, Corp.	Devices	02/17/2023	Lack of or inadequate complaint procedures
Ocean Blue International, Inc.	Food and Cosmetics	06/20/2023	Plant construction and design
Petnet Solutions, Inc.	Drugs	01/20/2023	Determination need for investigation
Petnet Solutions, Inc.	Drugs	01/20/2023	Orderly handling, prevention of mix-ups, prevention of contamination
Precision Align, LLC	Devices	07/20/2023	Lack of Written MDR Procedures
Precision Align, LLC	Devices	07/20/2023	Training records
Precision Align, LLC	Devices	07/20/2023	Evaluation of suppliers, contractors, etc., requirements
Precision Align, LLC	Devices	07/20/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Precision Align, LLC	Devices	07/20/2023	Lack of or inadequate receiving acceptance procedures
Precision Align, LLC	Devices	07/20/2023	Lack of or inadequate DHR procedures
Prime Line Distributors, Inc.	Food and Cosmetics	09/28/2023	Process preventive controls - Appropriate (Adequate)
Scott H. Schecter, O.D.	Drugs	02/06/2023	FD-1572, protocol compliance
Scott H. Schecter, O.D.	Drugs	02/06/2023	Case history records- inadequate or inadequate
Slater Endoscopy, LLC	Devices	02/02/2023	Procedures not adequately established or maintained
South Bear, Inc.	Food and Cosmetics	05/18/2023	Sanitary operations - Plant maintenance
South Bear, Inc.	Food and Cosmetics	05/18/2023	Toxic chemicals - Identified, held, stored
South Bear, Inc.	Food and Cosmetics	05/18/2023	Pest control
South Bear, Inc.	Food and Cosmetics	05/18/2023	Food safety plan - Preparation
South Bear, Inc.	Food and Cosmetics	05/18/2023	Hazard analysis - Conducted
Spinal Resources, Inc.	Devices	05/01/2023	Individual Report of Malfunction
Spinal Resources, Inc.	Devices	05/01/2023	Management review - defined interval, sufficient frequency
Spinal Resources, Inc.	Devices	05/01/2023	Quality Audits - defined intervals
Spinal Resources, Inc.	Devices	05/01/2023	Acceptable supplier records, inadequate records
Spinal Resources, Inc.	Devices	05/01/2023	Lack of or inadequate procedures - Acceptance activities
Spinal Resources, Inc.	Devices	05/01/2023	Nonconforming product, Lack of or inadequate procedures
Spinal Resources, Inc.	Devices	05/01/2023	Complaints
Spineup, Inc.	Devices	10/31/2023	Quality audits - auditor independence
Spineup, Inc.	Devices	10/31/2023	Training - Lack of or inadequate procedures
Spineup, Inc.	Devices	10/31/2023	Acceptable supplier records, inadequate records
Spineup, Inc.	Devices	10/31/2023	Lack of or inadequate final acceptance procedures
Spineup, Inc.	Devices	10/31/2023	Nonconforming product, Lack of or inadequate procedures
TMC International, Corp.	Food and Cosmetics	07/25/2023	Develop FSVP
Theweb2u.com, LLC	Devices	01/23/2023	Lack of System for Determining MDR Events
Theweb2u.com, LLC	Devices	01/23/2023	Quality audits - Lack of or inadequate procedures
Theweb2u.com, LLC	Devices	01/23/2023	Personnel
Theweb2u.com, LLC	Devices	01/23/2023	Design control - no procedures
Theweb2u.com, LLC	Devices	01/23/2023	Lack of procedures, or not maintained
Theweb2u.com, LLC	Devices	01/23/2023	Purchasing controls, Lack of or inadequate procedures
Theweb2u.com, LLC	Devices	01/23/2023	Lack of or inadequate final acceptance procedures
Theweb2u.com, LLC	Devices	01/23/2023	Lack of or inadequate procedures
Theweb2u.com, LLC	Devices	01/23/2023	DMR - not or inadequately maintained
Theweb2u.com, LLC	Devices	01/23/2023	Review and evaluation for investigation
Torito Brands, LLC	Food and Cosmetics	07/14/2023	Preventive Controls
Torito Brands, LLC	Food and Cosmetics	07/14/2023	Sanitation Controls
Torito Brands, LLC	Food and Cosmetics	07/14/2023	Environmental Monitoring
Torito Brands, LLC	Food and Cosmetics	07/14/2023	Written Product Testing Procedures
Torito Brands, LLC	Food and Cosmetics	07/14/2023	Revision of the Food Safety Plan Due To Reanalysis
Torito Brands, LLC	Veterinary	07/14/2023	Preventive Controls
Torito Brands, LLC	Veterinary	07/14/2023	Sanitation Controls
Torito Brands, LLC	Veterinary	07/14/2023	Environmental Monitoring
Torito Brands, LLC	Veterinary	07/14/2023	Written Product Testing Procedures
Torito Brands, LLC	Veterinary	07/14/2023	Revision of the Food Safety Plan Due To Reanalysis