There were seven companies in cities associated with Alameda County that received FDA citations as a result of seven inspections conducted in the county over the third quarter of 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 53.3% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
- Written procedures for sampling and testing plans are not followed for each drug product.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Drugs sector.
Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).
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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Equipment – design – appropriate and suitable |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Instruments – calibration |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Specifications – components |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Specifications – finished dietary supplement |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Component – qualify supplier |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Re-confirm certificate of analysis |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Specifications met – verify; finished batch |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Tests, examinations – scientifically valid |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Quality control production, process control; material review, disposition |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Master manufacturing record – specifications, quality; packaging, labeling |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Master manufacturing record – controls, procedures |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Batch record – each step |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Sampling plans; establish, follow |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Examination, testing; scientifically valid |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Manufacturing operations – sanitation |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | Written procedures – establish; returned dietary supplements |
| Advanced Food Concepts | Food and Cosmetics | 07/28/2025 | No AE report made (dietary supplement) |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | Hazard analysis |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | No HACCP plan |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | Sanitation Records |
| Global Commodities Corporation | Food and Cosmetics | 07/02/2025 | Importer verification |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Design input – Lack of or inadequate procedures |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Product rework procedures, Lack of or inadequate procedures |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Lack of or inadequate procedures |
| Medical Instrument Development Laboratories, Inc. | Devices | 08/13/2025 | Lack of or inadequate complaint procedures |
| Najafi Pharma, Inc. | Drugs | 07/09/2025 | Procedures not in writing, fully followed |
| Najafi Pharma, Inc. | Drugs | 07/09/2025 | Computer control of master formula records |
| Najafi Pharma, Inc. | Drugs | 07/09/2025 | Sampling and testing plans not followed |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | HACCP plan implementation |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | Critical control points |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | Calibration – adequacy |
| Ocean Queen USA, Inc. | Food and Cosmetics | 07/16/2025 | Sanitation monitoring |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Testing Each Component for Conformity with Specs |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Scientifically sound laboratory controls |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Investigations of discrepancies, failures |
| Sun Deep, Inc. | Drugs | 07/11/2025 | Complete test data included in records |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Hazard analysis written |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Document review entity’s hazard analysis |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Supplier approval – document |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Approved supplier procedures – importer established |
| T Rock, Inc. | Food and Cosmetics | 07/02/2025 | Supplier verification – establish written procedures |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
