North Boston News

There was one company in a city associated with Essex County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2024, 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 quarter.

The citations in the county include:

• The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
• Risk analysis is incomplete.
• Procedures for design change have not been adequately established.

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
Zoe Medical Incorporated	Devices	05/31/2024	Design validation - production units
Zoe Medical Incorporated	Devices	05/31/2024	Design Validation - Risk analysis not performed/inadequate
Zoe Medical Incorporated	Devices	05/31/2024	Design changes - Lack of or Inadequate Procedures
Zoe Medical Incorporated	Devices	05/31/2024	Evaluation of suppliers, contractors, etc., requirements
Zoe Medical Incorporated	Devices	05/31/2024	Lack of or inadequate procedures