There were five companies in cities associated with King County that received FDA citations as a result of five 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 a 400% increase over the number of companies cited in the previous quarter.
Of the 10 citations issued, the most common citations were ‘Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established’ and ‘Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established’.
Most of the companies cited were involved in either Devices or Drugs sectors.
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 |
|---|---|---|---|
| CurvaFix, Inc. | Devices | 04/24/2025 | Purchasing controls, Lack of or inadequate procedures |
| CurvaFix, Inc. | Devices | 04/24/2025 | Documentation |
| CurvaFix, Inc. | Devices | 04/24/2025 | Lack of or inadequate complaint procedures |
| Freespira, Inc. | Devices | 06/16/2025 | Purchasing controls, Lack of or inadequate procedures |
| Freespira, Inc. | Devices | 06/16/2025 | Lack of or inadequate procedures |
| Freespira, Inc. | Devices | 06/16/2025 | Lack of or inadequate complaint procedures |
| PETNET Solutions, Inc. | Drugs | 04/18/2025 | Equipment procedures |
| SSP America SEA, LLC | Food and Cosmetics | 04/23/2025 | Hazard analysis |
| SSP America SEA, LLC | Food and Cosmetics | 04/23/2025 | No HACCP plan |
| Seagen / Pfizer, Inc. | Drugs | 05/13/2025 | Training , Education , Experience overall |


