Interlab S.r.l. – FDA Warning Letter, Oct 25, 2012

During an FDA inspection from October 22-25, 2012, Interlab S.r.l. in Rome, Italy, was found to be in violation of Quality System (QS) regulation (21 CFR Part 820) for its Class I and II medical devices, including Immunofixation Electrophoresis Test Kits and Serum Protein Electrophoresis Test/Kits. The inspection revealed that the devices were adulterated under section 501(h) of the Act due to non-conformity with current good manufacturing practices.

Key violations included: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: The firm's Design Control Procedure was established only on October 23, 2012, and the Immunofixation Electrophoresis Test (cleared August 24, 2012) had not undergone design control. 2. **Failure to validate processes (21 CFR 820.75(a))**: The mixing process for the buffer used in Immunofixation gel plates was not validated. 3. **Incomplete process control procedures (21 CFR 820.70(a))**: The Gel Plate Production Procedure lacked requirements for documenting mixing time, specifying mixer speed, and contained discrepancies in mixing time requirements. 4. **Inadequate complaint handling procedures