West PDX Today

There was one company in a city associated with Washington County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 50% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
• Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.

The company cited was involved in the Drugs sector.

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.

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
Genentech, Inc.	Drugs	04/19/2024	Cleaning / Sanitizing / Maintenance
Genentech, Inc.	Drugs	04/19/2024	Written procedures not established/followed
Genentech, Inc.	Drugs	04/19/2024	Scientifically sound laboratory controls
Genentech, Inc.	Drugs	04/19/2024	Establishment of calibration procedures
Genentech, Inc.	Drugs	04/19/2024	Master production and control records, procedure
Genentech, Inc.	Drugs	04/19/2024	Written record of investigation incomplete
Genentech, Inc.	Drugs	04/19/2024	Testing Calculations