South King News

There were 25 companies in cities associated with King County that received FDA citations as a result of 26 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 19.4% decrease from the number of companies cited in the previous year.

Of the 68 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.

Of the companies cited, 24 should take voluntary actions to correct their managing operations (96%).

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
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	11/20/2023	Personnel
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	11/20/2023	Sanitary operations - Plant maintenance
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	11/20/2023	Manufacturing, processing, packing, holding - Controls
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	11/20/2023	Hazard analysis - Conducted
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	03/31/2023	Personnel
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	03/31/2023	Plant construction and design
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	03/31/2023	Equipment and utensils - Design and maintenance
Blazing Bagels & Bakery, Inc.	Food and Cosmetics	03/31/2023	Plant operations - Precautions
CurvaFix, Inc.	Devices	08/23/2023	Lack of System for Event Evaluations
CurvaFix, Inc.	Devices	08/23/2023	Justification for not reporting
CurvaFix, Inc.	Devices	08/23/2023	Quality Audit/Reaudit - conducted
CurvaFix, Inc.	Devices	08/23/2023	Purchasing controls, Lack of or inadequate procedures
CurvaFix, Inc.	Devices	08/23/2023	Lack of or inadequate procedures
CurvaFix, Inc.	Devices	08/23/2023	Sampling plans
Halogent, LLC	Food and Cosmetics	02/03/2023	Written procedures - holding
Halogent, LLC	Food and Cosmetics	02/03/2023	Written procedures - returned dietary supplement
Halogent, LLC	Food and Cosmetics	02/03/2023	Quality control - ensure quality; package, labeled, master record
Juniper Fine Foods, LLC	Food and Cosmetics	06/05/2023	Develop FSVP
Juniper Fine Foods, LLC	Food and Cosmetics	06/05/2023	Identification - entry
Juno Therapeutics, Inc.	Drugs	09/20/2023	Procedures not in writing, fully followed
Juno Therapeutics, Inc.	Drugs	09/20/2023	Written procedures not established/followed
Juno Therapeutics, Inc.	Drugs	09/20/2023	Procedures for sterile drug products
Kohtaro Food Corporation	Food and Cosmetics	10/19/2023	HACCP plan implementation
Kohtaro Food Corporation	Food and Cosmetics	10/19/2023	Corrective action per predetermined plan
LSG Sky Chefs, Inc.	Food and Cosmetics	12/20/2023	Allergen preventive controls - Implement
LSG Sky Chefs, Inc.	Food and Cosmetics	12/20/2023	Sanitation preventive controls - Appropriate (Adequate)
M & H Produce	Food and Cosmetics	11/02/2023	Storage and Distribution
Mamnoon, LLC	Food and Cosmetics	06/06/2023	Hazard analysis written
Mamnoon, LLC	Food and Cosmetics	06/06/2023	Evaluation - performance, risk
Mamnoon, LLC	Food and Cosmetics	06/06/2023	Approved supplier procedures - importer established
Mamnoon, LLC	Food and Cosmetics	06/06/2023	Supplier verification - establish written procedures
Nama, Inc.	Food and Cosmetics	03/23/2023	Develop FSVP
North American Trading, Corp.	Food and Cosmetics	04/21/2023	Develop FSVP
North30, LLC	Food and Cosmetics	03/28/2023	Develop FSVP
Powar Super Market, Inc.	Food and Cosmetics	12/08/2023	Develop FSVP
Powar Super Market, Inc.	Food and Cosmetics	12/08/2023	Hazard analysis written
Powar Super Market, Inc.	Food and Cosmetics	12/08/2023	Evaluation - performance, risk
Powar Super Market, Inc.	Food and Cosmetics	12/08/2023	Approved supplier procedures - importer established
Powar Super Market, Inc.	Food and Cosmetics	12/08/2023	Verification activity assurance
Powar Super Market, Inc.	Food and Cosmetics	12/08/2023	Audit - food safety regulation, plan
Probi USA International, Inc.	Food and Cosmetics	02/03/2023	Reprocessing, treatment, in-process adjustment - permitted
Probi USA International, Inc.	Food and Cosmetics	02/03/2023	Hold - temperature, humidity, light
Reliable Products, Inc.	Food and Cosmetics	09/28/2023	Pest control
Reliable Products, Inc.	Food and Cosmetics	09/28/2023	Supply-chain program - Implement
Richards Too Good Products, LLC	Food and Cosmetics	09/22/2023	Scheduled process
Seattle's Favorites, LLC	Food and Cosmetics	07/21/2023	Personnel
Seattle's Favorites, LLC	Food and Cosmetics	07/21/2023	Sanitary facilities and controls
Sharetea Issaquah, LLC	Food and Cosmetics	07/28/2023	Very small importer assurances, supplier
Siemens Medical Solutions USA, Inc.	Devices	01/06/2023	Design input - Lack of or inadequate procedures
Siemens Medical Solutions USA, Inc.	Devices	01/06/2023	Design verification - Lack of or inadequate procedures
Siemens Medical Solutions USA, Inc.	Devices	01/06/2023	Lack of or inadequate procedures
Siemens Medical Solutions USA, Inc.	Devices	01/06/2023	Lack of or inadequate complaint procedures
Siemens Medical Solutions USA, Inc.	Devices	01/06/2023	Sampling plans
The Napoleon Company	Food and Cosmetics	04/21/2023	Importer verification
Toaster labs, Inc.	Devices	04/04/2023	Lack of System for Event Evaluations
Toaster labs, Inc.	Devices	04/04/2023	Purchasing controls, Lack of or inadequate procedures
Toaster labs, Inc.	Devices	04/04/2023	Lack of or inadequate procedures
Tokai Denpun USA, Inc.	Food and Cosmetics	09/27/2023	Importer verification
Tokai Denpun USA, Inc.	Food and Cosmetics	09/27/2023	Determination of compliance
Tokai Denpun USA, Inc.	Food and Cosmetics	09/27/2023	Reportable food report - submission
Vam, LLC	Food and Cosmetics	01/27/2023	Food safety hazards
Vam, LLC	Food and Cosmetics	01/27/2023	Critical limits
Vam, LLC	Food and Cosmetics	01/27/2023	Verification - corrective action
Young Ocean, Inc.	Food and Cosmetics	03/03/2023	HACCP plan implementation
Young Ocean, Inc.	Food and Cosmetics	03/03/2023	Food safety hazards
Young Ocean, Inc.	Food and Cosmetics	03/03/2023	Corrective action per predetermined plan
Young Ocean, Inc.	Food and Cosmetics	03/03/2023	Sanitation monitoring documentation
Zipfizz Corporation	Food and Cosmetics	11/17/2023	Documentation - supplier qualification