DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- GMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them.
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
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 |
|---|---|---|---|
| Outlook Group, LLC | Drugs | 05/15/2025 | Procedures not in writing, fully followed |
| Outlook Group, LLC | Drugs | 05/15/2025 | GMP Training Frequency |
| Outlook Group, LLC | Drugs | 05/15/2025 | Computer control of master formula records |
| Outlook Group, LLC | Drugs | 05/15/2025 | Absence of Written Procedures |
Alerts Sign-up