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 quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- Routine checking of equipment is not performed according to a written program designed to assure proper performance.
The company cited was involved in the Drugs 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 |
|---|---|---|---|
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Procedures not in writing, fully followed |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Written procedures not established/followed |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Calibration/Inspection/Checking not done |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Absence of Written Procedures |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Strict control not exercised over labeling issued |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Storage under appropriate conditions |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Instruments, apparatus, et. al. not meeting specs |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Lack of written stability program |
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