Pierce Today

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

This is a 350% increase over the number of companies cited in the previous year.

Of the 36 citations issued, the most common citations include:

• Quality audits were not performed at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
• Procedures for training and identifying training needs have not been adequately established.
• The device history record does not include, or refer to the location of any unique device identifier (UDI) or universal product code (UPC).

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 Biologics sector.

Of the companies cited, eight should take voluntary actions to correct their managing operations (88.9%).

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
Blood Bank Computer Systems, Inc.	Biologics	06/30/2023	Quality Audits - defined intervals
Blood Bank Computer Systems, Inc.	Biologics	06/30/2023	Training - Lack of or inadequate procedures
Blood Bank Computer Systems, Inc.	Biologics	06/30/2023	DHR - UDI not included
Blood Bank Computer Systems, Inc.	Devices	06/30/2023	Quality Audits - defined intervals
Blood Bank Computer Systems, Inc.	Devices	06/30/2023	Training - Lack of or inadequate procedures
Blood Bank Computer Systems, Inc.	Devices	06/30/2023	DHR - UDI not included
Franco Fish Products	Food and Cosmetics	06/09/2023	HACCP plan implementation
Franco Fish Products	Food and Cosmetics	06/09/2023	Critical limits
Franco Fish Products	Food and Cosmetics	06/09/2023	Corrective action plan
Franco Fish Products	Food and Cosmetics	06/09/2023	Corrective action per predetermined plan
Franco Fish Products	Food and Cosmetics	06/09/2023	Verification - record review - frequency
Han Yang, Corp.	Food and Cosmetics	03/13/2023	Sanitary operations - Plant maintenance
Han Yang, Corp.	Food and Cosmetics	03/13/2023	Equipment and utensils - Design and maintenance
Han Yang, Corp.	Food and Cosmetics	03/13/2023	Manufacturing, processing, packing, holding - Controls
Heavenly Heat Gourmet Hot Sauces, LLC	Food and Cosmetics	11/29/2023	Process filing
Heavenly Heat Gourmet Hot Sauces, LLC	Food and Cosmetics	11/29/2023	Scheduled process
Medallion Foods, Inc.	Food and Cosmetics	05/24/2023	Pest control
Orient Seafood Production	Food and Cosmetics	05/02/2023	HACCP plan implementation
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Personnel - records - training
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Procedures - equipment - cleaning, sanitizing
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Specifications - labels, packaging
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Specifications - product received for packaging, labeling
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Product - visually examine, identified
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Reserve sample - collect, hold
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Written procedures - quality control operations
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Batch record - every batch
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Records - packaging, labeling operations
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Written procedures - holding; distributing
Sound Healing Arts, PC	Food and Cosmetics	01/19/2023	Written procedures - product complaint; review, investigate
Sun Sprout, LLC	Food and Cosmetics	07/10/2023	Training for supervisors
Sun Sprout, LLC	Food and Cosmetics	07/10/2023	Equip & tools - storage
Sun Sprout, LLC	Food and Cosmetics	07/10/2023	Food contact surface sanitary inspection and maintenance
Sun Sprout, LLC	Food and Cosmetics	07/10/2023	Written environmental monitoring plan
Sun Sprout, LLC	Food and Cosmetics	07/10/2023	Written sampling plan for spent irrigation water or sprouts
Tacoma-Pierce County Blood Bank	Biologics	05/26/2023	Written calibration / inspection records not kept
Tacoma-Pierce County Blood Bank	Biologics	05/26/2023	Equipment observed, standardized, calibrated