Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- Procedures for management review have not been established.
- Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
- Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
The company cited was involved in the Devices 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 |
|---|---|---|---|
| AirScan, Inc. | Devices | 03/24/2023 | Management review - Lack of or inadequate procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Quality Audits - defined intervals |
| AirScan, Inc. | Devices | 03/24/2023 | Purchasing controls, Lack of or inadequate procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Environmental control Lack of or inadequate procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Product rework procedures, Lack of or inadequate procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Lack of or inadequate procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Lack of or inadequate DHR procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Lack of or inadequate complaint procedures |
| AirScan, Inc. | Devices | 03/24/2023 | Sampling plans |
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