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 unchanged from the number of companies inspected in the previous quarter.
Most of the companies inspected at the time were involved in the Food and Cosmetics and Biologics sectors. The second most common type of company inspected worked in the Devices sector.
There were 11 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (64.7%). Six should take voluntary action to correct their management operations (35.3%).
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 | Result |
|---|---|---|---|
| 32 Bunga, Inc. | Food and Cosmetics | 10/11/2023 | No Action Indicated (NAI) |
| Azra Raza, M.D. | Drugs | 10/12/2023 | No Action Indicated (NAI) |
| Eye Bank For Sight Restoration, Inc. | Biologics | 11/13/2023 | Voluntary Action Indicated (VAI) |
| Forever Cheese, Inc. | Food and Cosmetics | 12/20/2023 | No Action Indicated (NAI) |
| Jeffrey W. Moses, M.D. | Devices | 12/14/2023 | No Action Indicated (NAI) |
| Laderach Lexington, LLC | Food and Cosmetics | 12/11/2023 | No Action Indicated (NAI) |
| Matthew J. Matasar, M.D. | Drugs | 10/26/2023 | No Action Indicated (NAI) |
| Mount Sinai Health System, Mount Sinai Hospital, Leon and Norma Hess Center for Science and Medicine | Biologics | 10/24/2023 | No Action Indicated (NAI) |
| New York Firefighters Skin Bank New York Presbyterian Hospital | Biologics | 12/19/2023 | No Action Indicated (NAI) |
| New York Presbyterian Hospital-Columbia University Med. Center | Biologics | 11/28/2023 | Voluntary Action Indicated (VAI) |
| Peter Charles Klatsky Inc., M.D. | Biologics | 11/06/2023 | No Action Indicated (NAI) |
| Pinnacle Fertility Labs New York | Biologics | 12/14/2023 | Voluntary Action Indicated (VAI) |
| Ports America, Inc. | Food and Cosmetics | 10/10/2023 | Voluntary Action Indicated (VAI) |
| Russian Shoppe, Inc. | Food and Cosmetics | 12/20/2023 | No Action Indicated (NAI) |
| Sunshine Wholesale Groc Company, Inc. | Food and Cosmetics | 12/14/2023 | No Action Indicated (NAI) |
| TMRW Life Sciences, Inc. | Devices | 10/24/2023 | Voluntary Action Indicated (VAI) |
| Xtreem Pulse, LLC | Devices | 10/13/2023 | Voluntary Action Indicated (VAI) |
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