Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 100% increase over the number of companies cited in the previous year.
Of the 19 citations issued, the most common citations were 'Procedures for corrective and preventive action have not been adequately established' and 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established'.
Most of the companies cited were involved in the Devices sector. The second most common type of company cited in the time period worked in the Food and Cosmetics 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| American Soy Products, Inc. | Food and Cosmetics | 08/16/2024 | Hazard analysis - Identification of hazard |
| American Soy Products, Inc. | Food and Cosmetics | 08/16/2024 | Allergen preventive controls - Implement |
| Axiobionics, LLC | Devices | 11/22/2024 | Management review - defined interval, sufficient frequency |
| Axiobionics, LLC | Devices | 11/22/2024 | Lack of or inadequate procedures |
| Axiobionics, LLC | Devices | 11/22/2024 | Investigation of device failures |
| Danmar Products, Inc. | Devices | 11/04/2024 | Training records |
| Danmar Products, Inc. | Devices | 11/04/2024 | Documented evaluation |
| Danmar Products, Inc. | Devices | 11/04/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Danmar Products, Inc. | Devices | 11/04/2024 | Documentation |
| Danmar Products, Inc. | Devices | 11/04/2024 | Lack of or inadequate receiving acceptance procedures |
| Danmar Products, Inc. | Devices | 11/04/2024 | Lack of or inadequate procedures |
| Danmar Products, Inc. | Devices | 11/04/2024 | Lack of or inadequate complaint procedures |
| David P. Fivenson, M.D. | Drugs | 05/23/2024 | FD-1572, protocol compliance |
| Green Hope, LLC | Food and Cosmetics | 03/18/2024 | Grounds |
| Green Hope, LLC | Food and Cosmetics | 03/18/2024 | Manufacturing, processing, packing, holding - Controls |
| Xoran Technologies, LLC | Devices | 07/11/2024 | Design Validation - Risk analysis not performed/inadequate |
| Xoran Technologies, LLC | Devices | 07/11/2024 | Design validation - software validation not performed |
| Xoran Technologies, LLC | Devices | 07/11/2024 | Purchasing controls, Lack of or inadequate procedures |
| Xoran Technologies, LLC | Devices | 07/11/2024 | Lack of or inadequate complaint procedures |
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