San Jose Standard

There were two companies in cities associated with Santa Clara County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county include:

• Your hazard analysis did not identify a hazard that required a preventive control.
• You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
• You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including protection of food, food packaging material, and food contact surfaces from adulteration and exclusion of pests.

Both 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
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
IL Pastaio	Food and Cosmetics	02/28/2024	Hazard analysis - Identification of hazard
IL Pastaio	Food and Cosmetics	02/28/2024	No HACCP plan
IL Pastaio	Food and Cosmetics	02/28/2024	Sanitation monitoring