Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website
This is an 80% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
- The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
- Procedures for acceptance activities have not been adequately established.
The company cited was involved in the Devices sector.
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 | 02/12/2024 | Individual Report of Malfunction |
Stericycle, Inc. | Devices | 02/12/2024 | Design history file |
Stericycle, Inc. | Devices | 02/12/2024 | Lack of or inadequate procedures - Acceptance activities |
Stericycle, Inc. | Devices | 02/12/2024 | Lack of or inadequate procedures |
Stericycle, Inc. | Devices | 02/12/2024 | Lack of or inadequate DHR procedures |
Stericycle, Inc. | Devices | 02/12/2024 | Lack of or inadequate complaint procedures |
Stericycle, Inc. | Devices | 02/12/2024 | Sampling methods - Lack of or inadequate procedures |