Hillsborough Sun

There was one company in a city associated with Hillsborough County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 75% decrease from the number of companies cited in the previous year.

The citations in the county include:

• An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
• Quality audits have not been performed.
• The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria and maintained.

The company cited should take a voluntary action to correct its managing operations.

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
SoClean, Inc.	Devices	02/06/2023	Individual Report of Malfunction
SoClean, Inc.	Devices	02/06/2023	Quality Audit/Reaudit - conducted
SoClean, Inc.	Devices	02/06/2023	Acceptance status
SoClean, Inc.	Devices	02/06/2023	Procedures for product review,disposition lack of/inadequate
SoClean, Inc.	Devices	02/06/2023	Lack of or inadequate DHR procedures