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# Violations in Uscom Spirometer Inspection
- URL: https://www.fdaweb.com/violations-in-uscom-spirometer-inspection/
- Published: 2025-08-27T12:00:00.000Z
- Updated: 2026-09-14T15:20:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159766

A 1/27-1/30 FDA inspection at the Uscom Kft facility in Budapest, Hungary, determined that the company is illegally manufacturing and marketing several spirometers for which it does not have an approved PMA or IDE in effect. A just-released 7/30 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/uscom-kft-708491-07302025?ref=fdaweb.com) also lists these Quality System Regulation violations:

- failure to adequately establish and maintain procedures for validating the device design;
- failure to establish and maintain procedures for implementing corrective and preventive action;
- failure to validate with a high degree of assurance a process where the results of a process cannot be fully verified by subsequent inspection and test;
- failure to establish and maintain procedures to control product that does not conform to specified requirements;
- failure to adequately maintain complaint files; and
- failure to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements.

The letter says the firm’s responses to the inspection observations were inadequate. It acknowledges the company’s statement that it does not intend to distribute its devices in the U.S. and reminds Uscom that it will be responsible for obtaining the appropriate clearance or approval if it decides to introduce its devices here.

Uscom was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.