Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
- The type and extent of control to be exercised over services and suppliers was not clearly defined.
- Products that do not conform to specifications are not adequately controlled.
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 |
|---|---|---|---|
| Troy Innovative Instruments, Inc. | Devices | 07/26/2024 | Management review - defined interval, sufficient frequency |
| Troy Innovative Instruments, Inc. | Devices | 07/26/2024 | Supplier oversight |
| Troy Innovative Instruments, Inc. | Devices | 07/26/2024 | Nonconforming product control |
| Troy Innovative Instruments, Inc. | Devices | 07/26/2024 | Documentation |
| Troy Innovative Instruments, Inc. | Devices | 07/26/2024 | Complaints |
Alerts Sign-up