There was one company in a city associated with Alameda County that received FDA citations as a result of one inspection conducted in the county in April, according to the U.S. Food and Drug Administration (FDA).
This is a 50% decrease from the number of companies cited in the previous month.
The citations in the county include:
- Written MDR procedures have not been developed.
- Records from management review were not adequately maintained.
- Process(es) for establishing competence, providing needed training and ensuring personnel awareness have not been adequately documented.
The company cited should take a voluntary action to correct its 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.
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 |
|---|---|---|---|
| All Quality & Services, Inc. | Devices | 04/10/2026 | Lack of Written MDR Procedures |
| All Quality & Services, Inc. | Devices | 04/10/2026 | Management review records not maintained |
| All Quality & Services, Inc. | Devices | 04/10/2026 | Process(es) for personnel competence, training and awareness not documented |
| All Quality & Services, Inc. | Devices | 04/10/2026 | Procedure for nonconforming product not documented |
| All Quality & Services, Inc. | Devices | 04/10/2026 | Corrective action procedures not documented |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
