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 70% increase over the number of companies inspected in the previous quarter, when 10 companies received 10 inspections.
Most of the companies inspected at the time were involved in the Food and Cosmetics sector. Both the Biologics and Drugs sectors sectors tied for second most common type.
There were 13 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (76.5%). Four should take voluntary action to correct their management operations (23.5%).
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 |
|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Drugs | 09/14/2023 | No Action Indicated (NAI) |
| Aveo Pharmaceuticals, Inc. | Drugs | 09/15/2023 | No Action Indicated (NAI) |
| Barbara L. Smith, PhD., M.D. | Devices | 08/04/2023 | No Action Indicated (NAI) |
| Beth Israel Deaconess Medical Center | Biologics | 09/11/2023 | No Action Indicated (NAI) |
| Boston Medical Center Corporation | Biologics | 09/12/2023 | No Action Indicated (NAI) |
| Community Suffolk, Inc. | Food and Cosmetics | 07/17/2023 | No Action Indicated (NAI) |
| Fleet Street Fruit Market, Inc. | Food and Cosmetics | 07/13/2023 | No Action Indicated (NAI) |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| MGH Fertility Center, Vincent Reproductive Medicine & IVF | Biologics | 09/21/2023 | No Action Indicated (NAI) |
| Mutual Produce, Corp. | Food and Cosmetics | 07/11/2023 | No Action Indicated (NAI) |
| New England Banana Company, Inc. | Food and Cosmetics | 08/28/2023 | No Action Indicated (NAI) |
| Peter Condakes Company, Inc. | Food and Cosmetics | 08/30/2023 | No Action Indicated (NAI) |
| RRG Holton, LLC | Food and Cosmetics | 08/18/2023 | Voluntary Action Indicated (VAI) |
| S. Strock & Company, Inc. | Food and Cosmetics | 07/12/2023 | No Action Indicated (NAI) |
| Servier US, Inc. | Drugs | 08/04/2023 | No Action Indicated (NAI) |
| Seven Hills Farmstead, LLC | Food and Cosmetics | 07/20/2023 | Voluntary Action Indicated (VAI) |
| Whele, LLC | Devices | 07/18/2023 | Voluntary Action Indicated (VAI) |
Alerts Sign-up