Sussex Review

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

This is a 200% increase over the number of companies cited in the previous year.

The citations in the county include:

• Your hazard analysis did not identify a hazard that requires a control.
• The organizational structure has not been established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
• Design validation did not ensure the device conforms to defined user needs and intended uses.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).

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
Sea Watch International, Ltd.	Food and Cosmetics	08/02/2023	HACCP plan implementation
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
VLM Foods USA, Ltd.	Food and Cosmetics	06/08/2023	Hazard analysis biological, chemical, physical