# FDA WARNING_LETTER - Interlab S.r.l. - October 25, 2012

Source: https://www.keypedia.com/records/warning_letter/interlab-srl/b7dde4b3-c697-401c-94fc-570a3bffba12

> FDA WARNING_LETTER for Interlab S.r.l. on October 25, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Interlab S.r.l.
- Inspection Date: 2012-10-25
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/alberto-gutierrez/ec16aa77-9dd3-4aff-aae4-1540ea96c5b8)

Company: https://www.keypedia.com/companies/interlab-srl/1321253a-13bb-4306-a943-8d86bb259bf1

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