There were 14 companies in a city associated with San Francisco County that received FDA citations as a result of 14 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 7.7% increase over the number of companies cited in the previous year.
Of the 44 citations issued, the most common citations were ‘Your sanitation control records do not accurately document the conditions or practices observed at your firm’ and ‘Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure the cause of the deviation was corrected’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, 12 should take voluntary actions to correct their managing operations (85.7%).
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.
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 |
|---|---|---|---|
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | HACCP plan implementation |
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | Critical control points |
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | Monitoring – adequacy |
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | Corrective action plan |
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | Verification procedures – adequacy |
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | Signed and dated |
| 2ByC, LLC | Food and Cosmetics | 09/15/2023 | Sanitation Records |
| Albeco, Inc. | Food and Cosmetics | 08/31/2023 | Manufacturing, processing, packing, holding – Controls |
| Four Star Seafood, Inc. | Food and Cosmetics | 08/17/2023 | Corrective action per predetermined plan |
| Four Star Seafood, Inc. | Food and Cosmetics | 08/17/2023 | Corrective action documentation |
| Four Star Seafood, Inc. | Food and Cosmetics | 08/17/2023 | Sanitation monitoring documentation |
| Golden Gate Soy Products, Inc. | Food and Cosmetics | 11/17/2023 | Process preventive controls – Implement |
| Golden Gate Soy Products, Inc. | Food and Cosmetics | 11/17/2023 | Preventive controls records – General requirements |
| Golden Gate Soy Products, Inc. | Food and Cosmetics | 11/17/2023 | Supply-chain program – Implement |
| Golden Gate Soy Products, Inc. | Food and Cosmetics | 11/17/2023 | Procedural requirements |
| Infinilush Company Limited | Food and Cosmetics | 08/29/2023 | Develop FSVP |
| Laurel Fertility Care, A Professional Medical Corporation | Biologics | 02/07/2023 | Determination based on screening and testing |
| Laurel Fertility Care, A Professional Medical Corporation | Biologics | 02/07/2023 | Accurate, indelible, legible |
| North America Foods Manufacturing, Inc. | Food and Cosmetics | 09/07/2023 | Sanitary operations – Plant sanitation |
| North America Foods Manufacturing, Inc. | Food and Cosmetics | 09/07/2023 | Equipment and utensils – Design and maintenance |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Food safety hazards |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Monitoring – adequacy |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Corrective action plan |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Verification procedures – adequacy |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Calibration – adequacy |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Records – content |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Sanitation monitoring |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Sanitation monitoring documentation |
| P & T Flannery Seafoods, Inc. | Food and Cosmetics | 08/17/2023 | Importer verification |
| Pacific Seafood – Eureka, LLC | Food and Cosmetics | 08/21/2023 | Sanitation monitoring |
| Rdm Express | Food and Cosmetics | 05/24/2023 | Develop FSVP |
| Rdm Express | Food and Cosmetics | 05/24/2023 | Supplier approval – document |
| The Fish Company | Food and Cosmetics | 12/11/2023 | HACCP plan implementation |
| The Fish Company | Food and Cosmetics | 12/11/2023 | Critical control points |
| The Fish Company | Food and Cosmetics | 12/11/2023 | Verification procedures – none/frequency |
| The Fish Company | Food and Cosmetics | 12/11/2023 | Sanitation monitoring documentation |
| The San Francisco Chocolate Factory, LLC | Food and Cosmetics | 09/05/2023 | Personnel |
| UCSF Health – Pediatric Cellular Therapy Laboratory | Biologics | 03/21/2023 | Computer software verification |
| UCSF Health – Pediatric Cellular Therapy Laboratory | Biologics | 03/21/2023 | Accurate, indelible, legible |
| Water2Table Fish, Inc. | Food and Cosmetics | 09/13/2023 | HACCP plan implementation |
| Water2Table Fish, Inc. | Food and Cosmetics | 09/13/2023 | Critical limits |
| Water2Table Fish, Inc. | Food and Cosmetics | 09/13/2023 | Corrective action plan |
| Water2Table Fish, Inc. | Food and Cosmetics | 09/13/2023 | Verification procedures – adequacy |
| Water2Table Fish, Inc. | Food and Cosmetics | 09/13/2023 | Signed and dated |
