Bristol Reporter

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

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

• Procedures for training and identifying training needs have not been established.
• Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
• Equipment calibrations, inspections, checks and maintenance activities have not been documented.

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
Professional Contract Sterilization, Inc.	Devices	02/16/2024	Training - Lack of or inadequate procedures
Professional Contract Sterilization, Inc.	Devices	02/16/2024	Contamination control, Lack of or inadequate procedures
Professional Contract Sterilization, Inc.	Devices	02/16/2024	Equipment control activity documentation
Professional Contract Sterilization, Inc.	Devices	02/16/2024	Lack of or inadequate process validation
Professional Contract Sterilization, Inc.	Devices	02/16/2024	Documentation
Professional Contract Sterilization, Inc.	Devices	02/16/2024	Documentation