There were eight companies in cities associated with Alameda County that received FDA citations as a result of eight inspections conducted in the county over the fourth quarter of 2023, 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 quarter.
Of the 29 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.
All of the companies cited should take voluntary actions to correct their managing operations.
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 |
|---|---|---|---|
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Hazard analysis biological, chemical, physical |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Document review entity’s hazard analysis |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Supplier approval – document |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Approved supplier procedures – importer established |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Supplier verification – establish written procedures |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Verification activity assurance |
| AMO and Wing, Inc. | Food and Cosmetics | 12/06/2023 | Verification activity before import, periodically |
| Acorn Trading, Inc. | Food and Cosmetics | 10/23/2023 | Qualifications of individuals |
| Acorn Trading, Inc. | Food and Cosmetics | 10/23/2023 | Storage and Distribution |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Personnel |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Sanitation of food-contact surfaces – Frequency |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Bake Fresh of Northern California, LLC | Food and Cosmetics | 11/16/2023 | Raw materials control – Microorganisms |
| JFC International, Inc. | Food and Cosmetics | 11/20/2023 | No HACCP plan |
| JFC International, Inc. | Food and Cosmetics | 11/20/2023 | Monitoring – adequacy |
| Organic Spices, Inc. | Food and Cosmetics | 10/24/2023 | Personnel |
| Organic Spices, Inc. | Food and Cosmetics | 10/24/2023 | Sanitary facilities and controls |
| Paramount Export Company | Food and Cosmetics | 11/29/2023 | Hazard analysis written |
| Paramount Export Company | Food and Cosmetics | 11/29/2023 | Evaluation – performance, risk |
| Paramount Export Company | Food and Cosmetics | 11/29/2023 | Approved supplier procedures – importer established |
| Paramount Export Company | Food and Cosmetics | 11/29/2023 | Supplier verification – establish written procedures |
| Softap, Inc. | Drugs | 12/11/2023 | Procedures not in writing, fully followed |
| Softap, Inc. | Drugs | 12/11/2023 | Training–operations, GMPs, written procedures |
| Softap, Inc. | Drugs | 12/11/2023 | Written distribution procedure |
| Softap, Inc. | Drugs | 12/11/2023 | Reserve samples identified, representative, stored |
| Softap, Inc. | Drugs | 12/11/2023 | Records reviewed annually |
| Softap, Inc. | Drugs | 12/11/2023 | Prepared for each batch, include complete information |
| Softap, Inc. | Drugs | 12/11/2023 | Complaint Handling Procedure |
| U. F. Union International Food, Inc. | Food and Cosmetics | 10/17/2023 | Personnel |
