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 year.
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.
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 |
|---|---|---|---|
| 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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