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 an increase over the number of companies cited in the previous month.
The citations in the county include:
- The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
- The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
- Requirements that must be met by suppliers have not been 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 |
|---|---|---|---|
| Penner Manufacturing, Inc. | Devices | 02/11/2025 | Label to bear a unique device identifier |
| Penner Manufacturing, Inc. | Devices | 02/11/2025 | Lack of System for Timely Submission of Reports |
| Penner Manufacturing, Inc. | Devices | 02/11/2025 | Evaluation of suppliers, contractors, etc., requirements |
| Penner Manufacturing, Inc. | Devices | 02/11/2025 | Lack of or inadequate procedures |
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