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 an 83.3% increase over the number of companies cited in the previous year.
Of the 38 citations issued, the most common citation was 'Risk analysis is inadequate'.
Most of the companies cited were involved in the Biologics sector. The second most common type of company cited in the time period worked in the either Devices or Food and Cosmetics sectors.
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 |
AmerisourceBergen Drug Corporation | Food and Cosmetics | 06/15/2023 | Reserve sample - collect, hold |
AmerisourceBergen Drug Corporation | Food and Cosmetics | 06/15/2023 | Quality control operations - returned dietary supplement |
AmerisourceBergen Drug Corporation | Food and Cosmetics | 06/15/2023 | Written procedures - holding |
AmerisourceBergen Drug Corporation | Food and Cosmetics | 06/15/2023 | Written procedures - returned dietary supplement |
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 |
Carolina Conceptions, PA | Biologics | 06/01/2023 | Determination based on screening and testing |
Carolina Conceptions, PA | Biologics | 06/01/2023 | Labeled re: biohazard, risks, test results |
CivaTech Oncology, Inc. | Devices | 06/14/2023 | Design input - documentation |
CivaTech Oncology, Inc. | Devices | 06/14/2023 | Design Validation - Risk analysis not performed/inadequate |
CivaTech Oncology, Inc. | Devices | 06/14/2023 | Lack of or inadequate final acceptance procedures |
CivaTech Oncology, Inc. | Devices | 06/14/2023 | DHR - not or inadequately maintained |
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 |
GlacierPoint Enterprises - Carolinas | Food and Cosmetics | 07/20/2023 | Grounds |
GlacierPoint Enterprises - Carolinas | Food and Cosmetics | 07/20/2023 | Sanitary operations - Plant maintenance |
GlacierPoint Enterprises - Carolinas | Food and Cosmetics | 07/20/2023 | Plant operations - Precautions |
GlacierPoint Enterprises - Carolinas | Food and Cosmetics | 07/20/2023 | Storage and Distribution |
Luminelle, Inc. | Devices | 02/21/2023 | Individual Report of Malfunction |
Luminelle, Inc. | Devices | 02/21/2023 | Management review - defined interval, sufficient frequency |
Luminelle, Inc. | Devices | 02/21/2023 | Training records |
Luminelle, Inc. | Devices | 02/21/2023 | Design verification - Lack of or inadequate procedures |
Luminelle, Inc. | Devices | 02/21/2023 | Design Validation - Risk analysis not performed/inadequate |
Luminelle, Inc. | Devices | 02/21/2023 | Evaluation of suppliers, contractors, etc., requirements |
Luminelle, Inc. | Devices | 02/21/2023 | Lack of or inadequate complaint procedures |
SpringWorks Therapeutics, Inc. | Drugs | 03/31/2023 | General responsibilities of sponsors |