Charleston Reporter

There were three companies in a city associated with Dorchester 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 an 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 required a preventive control.
• The evaluation of potential suppliers was not documented.
• Procedures for acceptance activities have not been established.

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

All of the companies cited should take voluntary actions to correct their 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
Carolina Sports and Orthopedics Sales, Inc.	Devices	03/01/2023	Documented evaluation
Carolina Sports and Orthopedics Sales, Inc.	Devices	03/01/2023	Lack of or inadequate procedures - Acceptance activities
Carolina Sports and Orthopedics Sales, Inc.	Devices	03/01/2023	Labeling inspection - UDI
Carolina Sports and Orthopedics Sales, Inc.	Devices	03/01/2023	Complaints
Carolina Sports and Orthopedics Sales, Inc.	Devices	03/01/2023	Servicing - Lack of or inadequate procedures
Limehouse Produce Company, Inc.	Food and Cosmetics	05/19/2023	Hazard analysis - Identification of hazard
Saffron, Inc.	Food and Cosmetics	07/12/2023	Sanitary operations - Plant maintenance
Saffron, Inc.	Food and Cosmetics	07/12/2023	Pest control
Saffron, Inc.	Food and Cosmetics	07/12/2023	Sanitation of food-contact surfaces - Frequency
Saffron, Inc.	Food and Cosmetics	07/12/2023	Food safety plan
Saffron, Inc.	Food and Cosmetics	07/12/2023	Supply-chain program - Records