Boise City Wire

There were three companies in a city associated with Ada County that received FDA citations as a result of three 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.

The citations in the county include:

• You did not develop an FSVP.
• The responsibilities and procedures applicable to the quality control unit are not in writing.
• Written standard operating procedures for all steps in the investigation of product deviations under the regulations were not established.

Most of the companies cited were involved in the Biologics 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
Saint Alphonsus Regional Medical Center	Biologics	05/04/2023	Procedures to expedite transfusions in emergencies
Saint Alphonsus Regional Medical Center	Biologics	05/04/2023	Biological product deviation report
St. Luke's Regional Medical Center	Biologics	05/04/2023	Procedures not in writing, fully followed
St. Luke's Regional Medical Center	Biologics	05/04/2023	SOPs for investigations, records
St. Luke's Regional Medical Center	Biologics	05/04/2023	Labeling procedures to avoid labeling mix-ups
St. Luke's Regional Medical Center	Biologics	05/04/2023	Required records - transfusion reaction and complaints
WinCo Foods, LLC	Food and Cosmetics	08/18/2023	Develop FSVP