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 an increase over the number of companies cited in the previous year.
The citations in the county include:
- Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
- 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.
- Laboratory records are deficient in that they do not include the location of the data that assures the accuracy and reliability of the test method.
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 |
|---|---|---|---|
| Element Materials Technology Midland, Inc. | Drugs | 05/23/2024 | Calibration/Inspection/Checking not done |
| Element Materials Technology Midland, Inc. | Drugs | 05/23/2024 | Computer control of master formula records |
| Element Materials Technology Midland, Inc. | Drugs | 05/23/2024 | Test methods ID and data location |
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