There were three companies in cities associated with Santa Clara County that received FDA citations as a result of three inspections conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- The written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
- 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.
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 |
|---|---|---|---|
| Greet Well, Inc. | Food and Cosmetics | 05/09/2025 | Supplier verification – establish written procedures |
| Greet Well, Inc. | Food and Cosmetics | 05/09/2025 | Identification – entry |
| LSG Sky Chefs #1393 | Food and Cosmetics | 04/25/2025 | Personnel |
| LSG Sky Chefs #1393 | Food and Cosmetics | 04/25/2025 | Process preventive controls – Implement |
| LSG Sky Chefs #1393 | Food and Cosmetics | 04/25/2025 | Sanitation preventive controls – Implement |
| Lifesignals, Inc. | Devices | 05/21/2025 | Lack of System for Event Evaluations |
| Lifesignals, Inc. | Devices | 05/21/2025 | Lack of or inadequate complaint procedures |
