How many companies in cities across Westchester County received FDA citations in Q1?

Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website

By Westchester Reporter

Apr 21, 2024

There were two companies in cities associated with Westchester County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county include:

Written MDR procedures have not been developed.
Records of complaint investigations are not maintained by the formally designated unit.
You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.

Both companies cited were involved in either Devices or Food and Cosmetics sectors.

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.

Companies located within Westchester County Cities and the citations they received in Q1

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
US Times Technology, Inc.	Food and Cosmetics	01/11/2024	Specifications - identity, purity, strength, composition
US Times Technology, Inc.	Food and Cosmetics	01/11/2024	Written procedures - quality control operations
US Times Technology, Inc.	Food and Cosmetics	01/11/2024	Written procedures - holding; distributing
US Times Technology, Inc.	Food and Cosmetics	01/11/2024	Written procedures - returned dietary supplement
US Times Technology, Inc.	Food and Cosmetics	01/11/2024	Written procedures - product complaint