There were two companies in cities associated with Lake County that received FDA citations as a result of two inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition.
- Your quality control operations for labeling did not include reviewing the results of documentation to ensure that established specifications were met for products that you receive for labeling.
- You did not establish written procedures for holding and distributing operations.
The companies cited were involved in either Food and Cosmetics or Devices sectors.
Both 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Novanto Technologies | Food and Cosmetics | 03/19/2025 | Specifications met – verify; finished batch |
| Novanto Technologies | Food and Cosmetics | 03/19/2025 | Quality control operations – labeling; visual examinations |
| Novanto Technologies | Food and Cosmetics | 03/19/2025 | Written procedures – establish; holding and distribution |
| XRD Dental Equipment | Devices | 01/31/2025 | Lack of Written MDR Procedures |
| XRD Dental Equipment | Devices | 01/31/2025 | Purchasing controls, Lack of or inadequate procedures |
| XRD Dental Equipment | Devices | 01/31/2025 | Lack of or inadequate procedures – Acceptance activities |
| XRD Dental Equipment | Devices | 01/31/2025 | Lack of or inadequate procedures |
| XRD Dental Equipment | Devices | 01/31/2025 | Lack of or inadequate procedures for storage. |
| XRD Dental Equipment | Devices | 01/31/2025 | Lack of or inadequate complaint procedures |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
