Strafford News

There was one company in a city associated with Strafford County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county include:

• Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
• 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.
• The specificity of test methods have not been established and documented.

The company cited was involved in the Drugs and Veterinary sectors.

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
University Instrumentation Center at UNH	Drugs	12/05/2023	Calibration/Inspection/Checking not done
University Instrumentation Center at UNH	Drugs	12/05/2023	Computer control of master formula records
University Instrumentation Center at UNH	Drugs	12/05/2023	Test methods
University Instrumentation Center at UNH	Drugs	12/05/2023	Second person sign off
University Instrumentation Center at UNH	Veterinary	12/05/2023	Calibration/Inspection/Checking not done
University Instrumentation Center at UNH	Veterinary	12/05/2023	Computer control of master formula records
University Instrumentation Center at UNH	Veterinary	12/05/2023	Test methods
University Instrumentation Center at UNH	Veterinary	12/05/2023	Second person sign off