FDA WARNING_LETTER - Analyticon Biotechnologies AG - March 29, 2012

On August 10, 2012, the FDA issued a Warning Letter to Analyticon Biotechnologies AG following an inspection from March 26-29, 2012, which found their Combi Screen Urine Test Strips to be adulterated. The inspection revealed non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Corrective and Preventive Action (CAPA) Procedures (21 CFR 820.100(a)(1)):** The firm's CAPA procedure (VA_AU_OR_006) lacks statistical methodology for analyzing data sources like complaints and non-conformities to determine when CAPA is required. Their response was inadequate, failing to specify how complaint trends would trigger CAPAs. 2. **Inspection, Measuring, and Test Equipment (21 CFR 820.72(a)):** The firm used unvalidated equipment for in-process and final QC testing of Combi Screen Plus urine test strips. Their response, stating they contacted independent labs for validation, was deemed insufficient without supporting documentation like SOPs or evidence of implementation.

Additionally, the firm made significant modifications to CombiScreen urine test strips (adding (b)(4) to alter performance) and distributed CombiScreen 10SL Plus and CombiScreen 11 SYS Plus without submitting new