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:
- Sampling plans are not based on valid statistical rationale.
- You did not develop an FSVP.
- Your hazard analysis did not identify a hazard that requires a control.
Both companies cited were involved in either Devices or Food and Cosmetics sectors.
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 |
|---|---|---|---|
| Asap Sons Group, Inc. | Food and Cosmetics | 04/09/2024 | Develop FSVP |
| Asap Sons Group, Inc. | Food and Cosmetics | 04/09/2024 | Hazard analysis biological, chemical, physical |
| Asap Sons Group, Inc. | Food and Cosmetics | 04/09/2024 | Document review entity's hazard analysis |
| Asap Sons Group, Inc. | Food and Cosmetics | 04/09/2024 | Evaluation - performance, risk |
| Asap Sons Group, Inc. | Food and Cosmetics | 04/09/2024 | Approved supplier procedures - importer established |
| Asap Sons Group, Inc. | Food and Cosmetics | 04/09/2024 | Verification activity before import, periodically |
| Qostronics | Devices | 05/23/2024 | Sampling plans |
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