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 37.5% decrease from the number of companies cited in the previous quarter.
Of the 11 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, three should take voluntary actions to correct their managing operations (60%). Additionally, one company had to take regulatory and/or administrative actions (20%).
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 |
|---|---|---|---|
| B & B Corner Corporation | Food and Cosmetics | 02/22/2024 | Develop FSVP |
| Beyond International, Inc. | Devices | 02/28/2024 | Form of a unique device identifier |
| Beyond International, Inc. | Devices | 02/28/2024 | Information used for annual reports |
| Beyond International, Inc. | Devices | 02/28/2024 | Nonconforming product, Lack of or inadequate procedures |
| Beyond International, Inc. | Devices | 02/28/2024 | Lack of or inadequate procedures |
| Beyond International, Inc. | Devices | 02/28/2024 | Servicing - Lack of or inadequate procedures |
| Beyond International, Inc. | Devices | 02/28/2024 | Failure to submit |
| Beyond International, Inc. | Devices | 02/28/2024 | Lack of certification |
| Family Fertility Center | Biologics | 01/30/2024 | Name and personal info on accompanying records |
| Rash Catering Services, LLC | Food and Cosmetics | 02/22/2024 | Develop FSVP |
| San Martin Distributing, Inc. | Food and Cosmetics | 01/04/2024 | Written procedures - holding |
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