West PDX Today

There were 12 companies in cities associated with Washington County that received FDA citations as a result of 12 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.

Of the 28 citations issued, the most common citation was 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices 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
Baker Commodities, Inc.	Veterinary	11/29/2023	Hazard Analysis
Classic Foods, Ltd.	Food and Cosmetics	08/04/2023	Allergen preventive controls - Implement
Classic Foods, Ltd.	Food and Cosmetics	08/04/2023	Process preventive controls - Identify (Written)
Classic Foods, Ltd.	Food and Cosmetics	08/04/2023	Sanitation preventive controls - Appropriate (Adequate)
HTO Nevada, Inc.	Food and Cosmetics	08/17/2023	Specifications met - test, examinations; compliance
HTO Nevada, Inc.	Food and Cosmetics	08/17/2023	Tests, examinations - scientifically valid
Jugetsudo by Maruyama nori, LLC	Food and Cosmetics	06/21/2023	Develop FSVP
Organic Partners International, LLC	Food and Cosmetics	12/07/2023	Identification - entry
Parks Medical Electronics, Inc.	Devices	06/15/2023	Maintenance schedule, Lack of or inadequate schedule
Parks Medical Electronics, Inc.	Devices	06/15/2023	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Parks Medical Electronics, Inc.	Devices	06/15/2023	Lack of or inadequate process validation
Parks Medical Electronics, Inc.	Devices	06/15/2023	Lack of or inadequate procedures
TNM Trade, LLC	Food and Cosmetics	07/12/2023	Develop FSVP
Thanh Son Foods, Inc.	Food and Cosmetics	12/22/2023	Personnel
Thanh Son Foods, Inc.	Food and Cosmetics	12/22/2023	Sanitary operations - Plant maintenance
Thanh Son Foods, Inc.	Food and Cosmetics	12/22/2023	Sanitary operations - Plant sanitation
Thanh Son Foods, Inc.	Food and Cosmetics	12/22/2023	Human food by-products
The Revelry Group, LLC	Food and Cosmetics	08/10/2023	Evaluation - performance, risk
The Revelry Group, LLC	Food and Cosmetics	08/10/2023	Approved supplier procedures - importer established
The Revelry Group, LLC	Food and Cosmetics	08/10/2023	Verification activity assurance
The Revelry Group, LLC	Food and Cosmetics	08/10/2023	Onsite audit
The Revelry Group, LLC	Food and Cosmetics	08/10/2023	Regulatory oversight
The Revelry Group, LLC	Food and Cosmetics	08/10/2023	Good compliance standing
Unbound Pickling, LLC	Food and Cosmetics	08/11/2023	Scheduled process
Unbound Pickling, LLC	Food and Cosmetics	08/11/2023	Process deviations- identification and records
Verdun Fine Chocolate & Gifts, Corp.	Food and Cosmetics	03/10/2023	Develop FSVP
Wayne M. Clark, M.D.	Devices	10/27/2023	Investigator non-compliance with agreement/plan/regulations
Wayne M. Clark, M.D.	Devices	10/27/2023	Investigator's subject records inadequate