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 unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been established.
- Procedures for the control of storage areas and stock rooms have not been established.
- A device history record has not been maintained.
Both 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 |
---|---|---|---|
American Red Cross Blood Services | Biologics | 10/16/2023 | Backup data not assured as exact and complete |
Avioq, Inc. | Biologics | 12/05/2023 | Identification procedures, Lack of or inadequate procedures |
Avioq, Inc. | Biologics | 12/05/2023 | Lack of or inadequate procedures for storage. |
Avioq, Inc. | Biologics | 12/05/2023 | DHR - not or inadequately maintained |