# FDA WARNING_LETTER - 77 Elektronika Kft. - March 12, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/77-elektronika-kft/67dada0e-b351-44a8-8c2f-018955e80be2

> FDA WARNING_LETTER for 77 Elektronika Kft. on March 12, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: 77 Elektronika Kft.
- Inspection Date: 2015-03-12
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On October 8, 2015, the FDA issued a Warning Letter to 77 Elektronika Kft. following an inspection from March 9-12, 2015, at their Budapest, Hungary facility. The inspection revealed that the firm's Urisys 1100 Urine Analyzer, a Class II medical device, was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included:
1.  **Failure to validate processes (21 CFR 820.75(a)):** The firm did not validate critical manufacturing processes for the Urisys 1100, including (b)(4) and (b)(4) processes. Their response, citing 100% functional testing, was deemed inadequate as it lacked evidence of systemic review, defined acceptance criteria, statistical rationale for sampling, and employee training plans.
2.  **Failure to monitor and control process parameters (21 CFR 820.75(b)):** Procedures for monitoring and controlling parameters for validated processes like (b)(4) were not established. The firm's response was inadequate for not providing evidence of a systemic retrospective review, defining monitoring procedures, or training employees.
3.  **Failure to control purchased product and

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)
- [Rudolf Tolgyesi](https://www.globalkeysolutions.net/people/rudolf-tolgyesi/18749913-3dc2-4f0d-bcf9-137668307976)

Company: https://www.globalkeysolutions.net/companies/77-elektronika-kft/26302acc-f61b-4a13-934d-acc5a6b6ad68

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7