Sussex Review

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

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not determine and document which verification activity or activities were needed to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
• You did not conduct and document or obtain documentation of one or more supplier verification activities.
• The organizational structure has not been established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).

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
Good Good Natural Sweetness, LLC	Food and Cosmetics	02/10/2023	Verification activity assurance
Good Good Natural Sweetness, LLC	Food and Cosmetics	02/10/2023	Verification activity before import, periodically
Sea Watch International, Ltd.	Food and Cosmetics	08/02/2023	HACCP plan implementation
Tail Bangers, Inc.	Veterinary	02/01/2023	Individual/Employee Qualifications
Tail Bangers, Inc.	Veterinary	02/01/2023	Plant Construction and Design
Tail Bangers, Inc.	Veterinary	02/01/2023	Work-in-Process and Rework
Tail Bangers, Inc.	Veterinary	02/01/2023	Food Safety Plan
Tesla Biohealing, Inc.	Devices	03/23/2023	Lack of or inadequate organizational structure
Tesla Biohealing, Inc.	Devices	03/23/2023	Design validation - user needs and intended uses
Tesla Biohealing, Inc.	Devices	03/23/2023	Evaluation and Selection, Suppliers, Contractors, etc.
Tesla Biohealing, Inc.	Devices	03/23/2023	Equipment suitability & capability