Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 500% increase over the number of companies cited in the previous year.
The citations in the county include:
- The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
- Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
- Procedures for design change have not been adequately established.
Most of the companies cited were involved in the Biologics sector.
All of the 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 |
---|---|---|---|
American Red Cross Blood Services | Biologics | 10/16/2023 | Backup data not assured as exact and complete |
Avioq, Inc. | Biologics | 12/05/2023 | Identification procedures, Lack of or inadequate procedures |
Avioq, Inc. | Biologics | 12/05/2023 | Lack of or inadequate procedures for storage. |
Avioq, Inc. | Biologics | 12/05/2023 | DHR - not or inadequately maintained |
Biogen U. S. Corporation | Biologics | 10/17/2023 | Control procedures to monitor and validate performance |
Biogen U. S. Corporation | Biologics | 10/17/2023 | Procedures for sterile drug products |
Biogen U. S. Corporation | Biologics | 10/17/2023 | Scientifically sound laboratory controls |
Biogen U. S. Corporation | Biologics | 10/17/2023 | Investigations of discrepancies, failures |
Biogen U. S. Corporation | Biologics | 10/17/2023 | Procedures to be written and followed |
Bleep, LLC | Devices | 08/25/2023 | Lack of or inadequate organizational structure |
Bleep, LLC | Devices | 08/25/2023 | Design plans - Lack of or inadequate |
Bleep, LLC | Devices | 08/25/2023 | Design changes - Lack of or Inadequate Procedures |
Bleep, LLC | Devices | 08/25/2023 | Purchasing controls, Lack of or inadequate procedures |
Bleep, LLC | Devices | 08/25/2023 | Documentation |
Concept Food Services Distributors, Inc. | Food and Cosmetics | 08/03/2023 | Hazard analysis biological, chemical, physical |
Concept Food Services Distributors, Inc. | Food and Cosmetics | 08/03/2023 | Approved supplier procedures - importer established |
SpringWorks Therapeutics, Inc. | Drugs | 03/31/2023 | General responsibilities of sponsors |