James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 66.7% decrease from the number of companies cited in the previous month.
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.
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 |
|---|---|---|---|
| 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 |
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