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 |
