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 unchanged from the number of companies cited in the previous year.
The citations in the county include:
- A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent.
- An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.
- Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.
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 |
|---|---|---|---|
| Allison Medical, Inc. | Devices | 04/28/2023 | Files do not contain copies of MDR reports |
| Allison Medical, Inc. | Devices | 04/28/2023 | Procedures not adequately established or maintained |
| Allison Medical, Inc. | Devices | 04/28/2023 | Software validation for automated processes |
| Allison Medical, Inc. | Devices | 04/28/2023 | Lack of or inadequate procedures |
| D. O. Weaver and Company | Devices | 05/12/2023 | Lack of or inadequate process validation |
| D. O. Weaver and Company | Devices | 05/12/2023 | Records of MDR Investigation |
| Lewis, Karl D., M.D. | Biologics | 08/07/2023 | Copy of consent form not provided |
| Lewis, Karl D., M.D. | Biologics | 08/07/2023 | FD-1572, protocol compliance |
| Lewis, Karl D., M.D. | Biologics | 08/07/2023 | Case history records- inadequate or inadequate |
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