Saratoga Standard

There were two companies in a city associated with Saratoga County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

• You did not have a written food safety plan.
• 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.
• Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

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
AgroChem USA, LLC	Veterinary	01/13/2023	Computer control of master formula records
AgroChem USA, LLC	Veterinary	01/13/2023	Testing Each Component for Conformity with Specs
AgroChem USA, LLC	Veterinary	01/13/2023	Lack of written stability program
AgroChem USA, LLC	Veterinary	01/13/2023	Annual visual exams of drug products
AgroChem USA, LLC	Veterinary	01/13/2023	Complaint Investigation/Follow-Up Findings
The Lazy Dog Cookie Company, Inc.	Veterinary	04/25/2023	Food Safety Plan