There were eight companies in cities associated with Sacramento County that received FDA citations as a result of nine inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 27.3% decrease from the number of companies cited in the previous year.
Of the 48 citations issued, the most common citation was ‘You did not take a reasonable measure or precaution related to personnel practices’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Veterinary sector.
Of the companies cited, eight should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (12.5%).
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.
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 |
|---|---|---|---|
| Bell Tasty Foods, Inc. | Food and Cosmetics | 02/29/2024 | Personnel |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Develop FSVP |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Document review entity’s hazard analysis |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Evaluation – performance, risk |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Approved supplier procedures – importer established |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Supplier verification – establish written procedures |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Verification activity assurance |
| International Wholesale Market, Inc. | Food and Cosmetics | 03/15/2024 | Verification activity before import, periodically |
| J & M Dairy | Veterinary | 03/04/2024 | Prescribed directions – not followed |
| J & M Dairy | Veterinary | 03/04/2024 | ELDU – producer causes Illegal drug residue |
| J & M Dairy | Veterinary | 03/04/2024 | Individual identity of animal(s) |
| J & M Dairy | Veterinary | 03/04/2024 | Record keeping |
| New World Company | Food and Cosmetics | 01/18/2024 | Qualifications of individuals |
| New World Company | Food and Cosmetics | 01/18/2024 | Personnel |
| New World Company | Food and Cosmetics | 01/18/2024 | Equipment and utensils – Design and maintenance |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Label to bear a unique device identifier |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Management representative |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Management review – Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Quality audits – Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Training – Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Design validation- Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Procedures not adequately established or maintained |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Purchasing controls, Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Process control procedures, Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Production and Process Change Procedures, lack of or Inad. |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Contamination control, Lack of or inadequate procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Lack of or inadequate process validation |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Lack of or inadequate DHR procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Lack of or inadequate complaint procedures |
| OrthoGroup, Inc. | Devices | 02/02/2024 | Devices subject to device identification GUDID data submission requirements. |
| Tanoa Imports, Inc. | Food and Cosmetics | 02/29/2024 | Develop FSVP |
| The Posh Bakery, Inc. | Food and Cosmetics | 09/03/2024 | Personnel |
| The Posh Bakery, Inc. | Food and Cosmetics | 09/03/2024 | Sanitary operations – Plant sanitation |
| The Posh Bakery, Inc. | Food and Cosmetics | 09/03/2024 | Equipment and utensils – Design and maintenance |
| The Posh Bakery, Inc. | Veterinary | 09/03/2024 | Personnel |
| The Posh Bakery, Inc. | Veterinary | 09/03/2024 | Sanitary operations – Plant sanitation |
| The Posh Bakery, Inc. | Veterinary | 09/03/2024 | Equipment and utensils – Design and maintenance |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 03/01/2024 | Personnel |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 03/01/2024 | Sanitary operations – Plant maintenance |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 03/01/2024 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 03/01/2024 | Equipment and utensils – Design and maintenance |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 03/01/2024 | Plant operations – Precautions |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 11/15/2024 | Personnel |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 11/15/2024 | Sanitary operations – Plant maintenance |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 11/15/2024 | Sanitary facilities and controls |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 11/15/2024 | Equipment and utensils – Design and maintenance |
| Wa Heng Dou Fu and Soy Sauce Corporation | Food and Cosmetics | 11/15/2024 | Plant operations – Precautions |
