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 an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for design transfer have not been adequately established.
- There is no agreement with suppliers to notify you of changes in the product or service.
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
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 |
|---|---|---|---|
| The Morel Company, LLC | Devices | 07/02/2024 | Design transfer - Lack of or inadequate procedures |
| The Morel Company, LLC | Devices | 07/02/2024 | Supplier notification of changes |
| The Morel Company, LLC | Devices | 07/02/2024 | Lack of or inadequate process validation |
| The Morel Company, LLC | Devices | 07/02/2024 | Lack of or inadequate procedures - Acceptance activities |
| The Morel Company, LLC | Devices | 07/02/2024 | Product rework procedures, Lack of or inadequate procedures |
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