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 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- Complaint files are not adequately maintained.
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
- Quality audits have not been performed.
Both companies cited should take voluntary actions to correct their 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 |
|---|---|---|---|
| Azer Scientific, Inc. | Devices | 12/04/2023 | Complaints |
| Lifeaire Systems | Devices | 08/29/2023 | Management review - defined interval, sufficient frequency |
| Lifeaire Systems | Devices | 08/29/2023 | Quality Audit/Reaudit - conducted |
| Lifeaire Systems | Devices | 08/29/2023 | Evaluation of suppliers, contractors, etc., requirements |
| Lifeaire Systems | Devices | 08/29/2023 | Lack of or inadequate complaint procedures |
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