Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
- Procedures for the acceptance of in-process product have not been adequately established.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
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 |
---|---|---|---|
NG Instruments, Inc. | Devices | 12/14/2023 | Lack of or inadequate process validation |
NG Instruments, Inc. | Devices | 12/14/2023 | Lack of or inadequate In-process acceptance procedures |
NG Instruments, Inc. | Devices | 12/14/2023 | Nonconforming product, Lack of or inadequate procedures |