Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 33.3% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Written MDR procedures have not been developed.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
- Complaint files are not adequately maintained.
Most 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 |
|---|---|---|---|
| Efficient Laboratories, Inc. | Food and Cosmetics | 04/25/2024 | Specifications met - quality |
| Efficient Laboratories, Inc. | Food and Cosmetics | 04/25/2024 | Written procedures - quality control operations |
| Efficient Laboratories, Inc. | Food and Cosmetics | 04/25/2024 | Processes, specifications, written procedures |
| Efficient Laboratories, Inc. | Food and Cosmetics | 04/25/2024 | Quality control - supplier qualification |
| Efficient Laboratories, Inc. | Food and Cosmetics | 04/25/2024 | Quality control - batch, product specifications |
| Legend Aerospace, Inc. | Devices | 05/01/2024 | Lack of Written MDR Procedures |
| Legend Aerospace, Inc. | Devices | 05/01/2024 | Purchasing controls, Lack of or inadequate procedures |
| Legend Aerospace, Inc. | Devices | 05/01/2024 | Complaints |
| Medas, Inc. | Devices | 04/26/2024 | Procedures not adequately established or maintained |
| Medas, Inc. | Devices | 04/26/2024 | Lack of or inadequate procedures |
| Medas, Inc. | Devices | 04/26/2024 | Lack of or inadequate procedures for storage. |
| Medas, Inc. | Devices | 04/26/2024 | Lack of or inadequate complaint procedures |
| Skeletal Dynamics, Inc. | Devices | 04/05/2024 | Not approved or obsolete document retrieval |
| Skeletal Dynamics, Inc. | Devices | 04/05/2024 | Purchasing controls, Lack of or inadequate procedures |
| Skeletal Dynamics, Inc. | Devices | 04/05/2024 | Maintenance schedule, Lack of or inadequate schedule |
| Skeletal Dynamics, Inc. | Devices | 04/05/2024 | Lack of or inadequate receiving acceptance procedures |
| Skeletal Dynamics, Inc. | Devices | 04/05/2024 | Lack of or inadequate DHR procedures |
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