Greenville Leader

There were three companies in cities associated with Greenville 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 50% increase over the number of companies cited in the previous year.

The citations in the county include:

• Document control procedures have not been established and maintained.
• Process validation activities and results have not been documented and approved.
• In-process inspections, tests, or other verification activities and approvals were not documented.

All of the companies cited were involved in either Devices, Drugs, or Food and Cosmetics sectors.

Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%).

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
Earth's Creation USA	Food and Cosmetics	07/20/2023	Quality control operations - batch production records
Earth's Creation USA	Food and Cosmetics	07/20/2023	Records - quality control operations; responsibilities
Earth's Creation USA	Food and Cosmetics	07/20/2023	Batch record - complete
Earth's Creation USA	Food and Cosmetics	07/20/2023	Manufacturing operations - design
Prisma Health Outsourcing Facility	Drugs	03/03/2023	Procedures not in writing, fully followed
Prisma Health Outsourcing Facility	Drugs	03/03/2023	Floors, walls, ceiling surfaces
Prisma Health Outsourcing Facility	Drugs	03/03/2023	Procedures for sterile drug products
Span Packaging Services, LLC	Devices	06/15/2023	Lack of procedures, or not maintained
Span Packaging Services, LLC	Devices	06/15/2023	Documentation
Span Packaging Services, LLC	Devices	06/15/2023	Documentation
Span Packaging Services, LLC	Devices	06/15/2023	Documentation
Span Packaging Services, LLC	Devices	06/15/2023	Complaints