James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- Procedures for design verification have not been adequately established.
- Procedures for design validation have not been adequately established.
- Procedures for corrective and preventive action have not been adequately established.
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 |
---|---|---|---|
Murata Vios, Inc. | Devices | 12/11/2024 | Design verification - Lack of or inadequate procedures |
Murata Vios, Inc. | Devices | 12/11/2024 | Design validation- Lack of or inadequate procedures |
Murata Vios, Inc. | Devices | 12/11/2024 | Lack of or inadequate procedures |