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

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