East King News

There were two companies in cities associated with King County that received FDA citations as a result of two inspections conducted in the county in July, 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 month.

The citations in the county include:

• Procedures for design control have not been established.
• Documents were not available at all locations for which they are designated, used, or otherwise necessary.
• Records of acceptable contractors have not been adequately established.

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
E&E Foods, Inc.	Food and Cosmetics	07/29/2024	Importer verification
Personal Medical Corporation	Devices	07/16/2024	Design control - no procedures
Personal Medical Corporation	Devices	07/16/2024	Document locations, Dissemination, etc.
Personal Medical Corporation	Devices	07/16/2024	Acceptable supplier records, inadequate records
Personal Medical Corporation	Devices	07/16/2024	Lack of or inadequate procedures