Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- Procedures for design control have not been established.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
The companies cited were involved in either Devices or Veterinary sectors.
Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Best Buy Bones, Inc. | Veterinary | 05/03/2024 | Hazard Analysis |
| Best Buy Bones, Inc. | Veterinary | 05/03/2024 | Preventive Controls |
| Best Buy Bones, Inc. | Veterinary | 05/03/2024 | Written Preventive Controls |
| Best Buy Bones, Inc. | Veterinary | 05/03/2024 | Monitoring Records for Preventive Controls |
| Best Buy Bones, Inc. | Veterinary | 05/03/2024 | Supply-Chain Program Establish and Implement |
| Ease Seating Systems, Inc. | Devices | 04/30/2024 | Design control - no procedures |
| Ease Seating Systems, Inc. | Devices | 04/30/2024 | Purchasing controls, Lack of or inadequate procedures |
| Ease Seating Systems, Inc. | Devices | 04/30/2024 | Lack of or inadequate complaint procedures |
| Ease Seating Systems, Inc. | Devices | 04/30/2024 | GUDID Information required for unique device identification. |
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