How many companies in cities across Spokane County received FDA citations in 2024?

There was one company in a city associated with Spokane County that received FDA citations as a result of one inspection conducted in the county throughout 2024, 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 year.

The citations in the county include:

• Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet audit trail and employee accountability/responsibility policy requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
• Specific identification tests are not conducted on components that have been accepted based on the supplier’s report of analysis.
• Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

The company cited should take a voluntary action to correct its 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.

According to its website, 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.