Asheville Reporter

There were three companies in a city associated with Buncombe 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.

Of the 12 citations issued, the most common citations were 'The responsibilities and procedures applicable to the quality control unit are not fully followed' and 'Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed'.

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

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
Green Sprouts	Devices	08/16/2023	Management review - defined interval, sufficient frequency
Green Sprouts	Devices	08/16/2023	Management review - Lack of or inadequate procedures
Green Sprouts	Devices	08/16/2023	Quality Audit/Reaudit - conducted
Green Sprouts	Devices	08/16/2023	Documented evaluation
Green Sprouts	Devices	08/16/2023	Supplier notification of changes
Green Sprouts	Devices	08/16/2023	Lack of or inadequate procedures for labeling
JMJ Tomato Company, Inc.	Food and Cosmetics	08/24/2023	Qualifications of individuals
JMJ Tomato Company, Inc.	Food and Cosmetics	08/24/2023	Plant construction and design
King Bio, Inc.	Drugs	07/28/2023	Procedures not in writing, fully followed
King Bio, Inc.	Drugs	07/28/2023	Procedures for non-sterile drug products
King Bio, Inc.	Veterinary	07/28/2023	Procedures not in writing, fully followed
King Bio, Inc.	Veterinary	07/28/2023	Procedures for non-sterile drug products