There were six companies in a city associated with San Francisco County that received FDA citations as a result of six inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 60% decrease from the number of companies cited in the previous year.
The citations in the county include:
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier’s performance.
- You did not develop an FSVP.
- Deviation from the procedural requirements of a decree of injunction.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, four should take voluntary actions to correct their managing operations (66.7%). 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 |
|---|---|---|---|
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Sanitary operations – Plant sanitation |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Pest control |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Equipment and utensils – Design and maintenance |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Raw material control – Inspection |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Manufacturing, processing, packing, holding – Controls |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Process control – Foreign objects |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Hazard analysis – Identification of hazard |
| Fong Kee Tofu Company, Inc. | Food and Cosmetics | 05/15/2024 | Process preventive controls – Appropriate (Adequate) |
| Golden Gate Soy Products, Inc. | Food and Cosmetics | 07/29/2024 | Procedural requirements |
| Hosoda Bros., Inc. | Food and Cosmetics | 04/01/2024 | Develop FSVP |
| Knox Medical Diagnostics, Inc. | Devices | 08/21/2024 | Results of evaluation not in mfr’s MDR file |
| Knox Medical Diagnostics, Inc. | Devices | 08/21/2024 | Records of complaint investigation |
| Lotus Bakeries North America, Inc. | Food and Cosmetics | 05/23/2024 | Evaluation – performance, risk |
| Nest Cryobank, LLC | Biologics | 09/17/2024 | Donors with risks not determined ineligible |
