SE Kansas City News

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

This is a 50% decrease from the number of companies cited in the previous year.

The citations in the county include:

• You did not develop an FSVP.
• Personnel training is not documented.
• Procedures for design control have not been established.

The companies cited were involved in either Veterinary or Devices sectors.

Both 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
S-Community, Inc.	Devices	05/17/2023	Training records
S-Community, Inc.	Devices	05/17/2023	Design control - no procedures
S-Community, Inc.	Devices	05/17/2023	Purchasing controls, Lack of or inadequate procedures
S-Community, Inc.	Devices	05/17/2023	Nonconforming product, Lack of or inadequate procedures
S-Community, Inc.	Devices	05/17/2023	Lack of or inadequate procedures
S-Community, Inc.	Devices	05/17/2023	Lack of or inadequate complaint procedures
Sponge Company, Inc.	Veterinary	08/15/2023	Develop FSVP