Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 45.5% decrease from the number of companies cited in the previous quarter.
Of the 26 citations issued, the most common citation was 'The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed'.
Most of the companies cited were involved in the Devices sector.
Of the companies cited, five should take voluntary actions to correct their managing operations (83.3%). Additionally, one company had to take regulatory and/or administrative actions (16.7%).
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 |
|---|---|---|---|
| Advanced Instrumentations, Inc. | Devices | 02/26/2024 | Design history file |
| Advanced Instrumentations, Inc. | Devices | 02/26/2024 | Procedures not adequately established or maintained |
| Advanced Instrumentations, Inc. | Devices | 02/26/2024 | Purchasing controls, Lack of or inadequate procedures |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Report of Death or Serious Injury |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Individual Report of Malfunction |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Documentation |
| BioTissue Holdings, Inc. | Devices | 03/06/2024 | Investigation of device failures |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Personnel |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Sanitary operations - Plant sanitation |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Toxic chemicals - Identified, held, stored |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Pest control |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Sanitary facilities and controls |
| Charanga Catering, LLC | Food and Cosmetics | 03/06/2024 | Manufacturing, processing, packing, holding - Controls |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Procedures not in writing, fully followed |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Defined areas of adequate size for operations |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Buildings not maintained in good state of repair |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Identity Testing of Each Component |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Absence of Written Procedures |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Testing and release for distribution |
| Custom Manufacturing Corporation | Veterinary | 01/11/2024 | Lack of written stability program |
| EUSA Global, LLC | Devices | 03/22/2024 | Management review - defined interval, sufficient frequency |
| EUSA Global, LLC | Devices | 03/22/2024 | Nonconforming product, Lack of or inadequate procedures |
| EUSA Global, LLC | Devices | 03/22/2024 | Lack of or inadequate procedures for labeling |
| EUSA Global, LLC | Devices | 03/22/2024 | Lack of or inadequate complaint procedures |
| Medipharm Laboratories, Inc. | Drugs | 02/23/2024 | Procedures not in writing, fully followed |
| Medipharm Laboratories, Inc. | Drugs | 02/23/2024 | Training--operations, GMPs, written procedures |
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