Monroe NY News

There were three companies in cities associated with Monroe County that received FDA citations as a result of three inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 62.5% decrease from the number of companies cited in the previous year.

Of the 23 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

All of the companies cited were involved in the Devices sector.

All of the 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.

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
First Source, Inc.	Devices	09/19/2023	Design changes - Lack of or Inadequate Procedures
First Source, Inc.	Devices	09/19/2023	Lack of or inadequate final acceptance procedures
First Source, Inc.	Devices	09/19/2023	Nonconforming product, Lack of or inadequate procedures
First Source, Inc.	Devices	09/19/2023	Lack of or inadequate procedures
First Source, Inc.	Devices	09/19/2023	Basis for selecting methods, devices, procedures
First Source, Inc.	Devices	09/19/2023	Tube housing assemblies (leakage technique factors)
First Source, Inc.	Devices	09/19/2023	Tube housing assemblies - cooling curves
Turbett Surgical, Inc.	Devices	06/26/2023	Management review - Lack of or inadequate procedures
Turbett Surgical, Inc.	Devices	06/26/2023	Quality audits - Lack of or inadequate procedures
Turbett Surgical, Inc.	Devices	06/26/2023	Training records
Turbett Surgical, Inc.	Devices	06/26/2023	Design validation- Lack of or inadequate procedures
Turbett Surgical, Inc.	Devices	06/26/2023	Design transfer - Lack of or inadequate procedures
Turbett Surgical, Inc.	Devices	06/26/2023	Design changes - Lack of or Inadequate Procedures
Turbett Surgical, Inc.	Devices	06/26/2023	Lack of or inadequate process validation
Turbett Surgical, Inc.	Devices	06/26/2023	Lack of or inadequate procedures
Turbett Surgical, Inc.	Devices	06/26/2023	Lack of or inadequate complaint procedures