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 a 50% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for corrective and preventive action have not been adequately established.
- The DHR does not include records of examination and release of device labeling, including date and signature of the examiner.
- A device history record has not been adequately maintained.
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 |
---|---|---|---|
Technical Products, Inc. | Devices | 07/25/2024 | Lack of or inadequate procedures |
Technical Products, Inc. | Devices | 07/25/2024 | DHR documentation of label release {see also 820.184} |
Technical Products, Inc. | Devices | 07/25/2024 | DHR - not or inadequately maintained |