South SFV Today

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

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

• No management representative had been appointed to ensure that quality system requirements are met, and to report to management on the performance of the quality system.
• Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
• 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.

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
Algomedica, Inc.	Devices	03/28/2024	Management representative
Algomedica, Inc.	Devices	03/28/2024	Management review - defined interval, sufficient frequency
Algomedica, Inc.	Devices	03/28/2024	Quality Audits - defined intervals