Westchester Reporter

There was one company in a city associated with Westchester 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 unchanged from the number of companies cited in the previous month.

The citations in the county were 'Written MDR procedures have not been developed' and 'Records of complaint investigations are not maintained by the formally designated unit'.

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
Ambulatory Monitoring, Inc.	Devices	02/29/2024	Lack of Written MDR Procedures
Ambulatory Monitoring, Inc.	Devices	02/29/2024	Maintained