Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 66.7% decrease from 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.
- Procedures for quality audits have not been adequately established.
- Procedures for corrective and preventive action have not been adequately 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.
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 |
---|---|---|---|
Stericycle, Inc. | Devices | 12/21/2023 | Management review - defined interval, sufficient frequency |
Stericycle, Inc. | Devices | 12/21/2023 | Quality audits - Lack of or inadequate procedures |
Stericycle, Inc. | Devices | 12/21/2023 | Lack of or inadequate procedures |