There was one company in a city associated with Santa Clara County that received FDA citations as a result of one inspection conducted in the county in March, according to the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- Top management did not adequately review the quality management system at documented planned intervals to ensure its continued suitability, adequacy, and effectiveness.
- One or more processes for risk management in product realization have not been adequately documented.
- Procedures to ensure that purchased product conforms to specified purchasing information have not been adequately documented.
The company cited was involved in the Devices sector.
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 |
|---|---|---|---|
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | QMS not reviewed by top management at documented planned intervals |
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | Product realization risk management processes not documented |
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | Procedures for purchasing process not documented |
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | Procedures for product identification not documented |
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | Lack of documented justification for not investigating complaint(s) |
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| Unik Orthopedics, Inc. | Devices | 03/13/2026 | 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.



