Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 75% decrease from the number of companies cited in the previous month.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
- Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair.
The company cited was involved in the Veterinary sector.
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 |
|---|---|---|---|
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Procedures not in writing, fully followed |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Defined areas of adequate size for operations |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Buildings not maintained in good state of repair |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Identity Testing of Each Component |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Absence of Written Procedures |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Testing and release for distribution |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Lack of written stability program |
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