Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals.
- Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
- Complaint files are not 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.
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 |
|---|---|---|---|
| Dorel Juvenile Group, Inc. | Devices | 04/25/2024 | Management review - defined interval, sufficient frequency |
| Dorel Juvenile Group, Inc. | Devices | 04/25/2024 | Quality Audits - defined intervals |
| Dorel Juvenile Group, Inc. | Devices | 04/25/2024 | Complaints |
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