Rochester Reporter

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

The citations in the county include:

• Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
• Design input requirements were not documented.
• The design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.

The company cited was involved in the Devices sector.

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
DJ Acquisition FTT, LLC	Devices	10/12/2023	Design plans - Lack of or inadequate
DJ Acquisition FTT, LLC	Devices	10/12/2023	Design input - documentation
DJ Acquisition FTT, LLC	Devices	10/12/2023	Design review - documentation
DJ Acquisition FTT, LLC	Devices	10/12/2023	Design verification - documentation
DJ Acquisition FTT, LLC	Devices	10/12/2023	Design validation - documentation
DJ Acquisition FTT, LLC	Devices	10/12/2023	Nonconforming product, Lack of or inadequate procedures
DJ Acquisition FTT, LLC	Devices	10/12/2023	Lack of or inadequate procedures