# FDA WARNING_LETTER - I.T.S. GmbH - January 19, 2023

Source: https://www.keypedia.com/records/warning_letter/its-gmbh/58478b44-b734-4a69-9f46-af323495dd19

> FDA WARNING_LETTER for I.T.S. GmbH on January 19, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: I.T.S. GmbH
- Inspection Date: 2023-01-19
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 16-19, 2023, an FDA inspection of Autal in Lassnithohe, Austria, revealed that their bone fixation and other Class II devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's response dated February 7 and March 20, 2023, was deemed inadequate.

Key violations include:
1.  **Failure to adequately establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA System procedure (ITS PB-7.6-2 Edition 9) lacked adequate requirements for investigating nonconformities, implementing/recording changes, and disseminating information. A specific instance involved an inadequate investigation of dimensional deviations from a supplier. While a revised procedure (Revision 10) and CAPA form were provided, evidence of training for all relevant personnel and a review of prior CAPAs per the revised procedure were not.

2.  **Failure to maintain adequate Device History Records (DHRs) (21 CFR 820.184)**: The firm did not document the primary identification label and labeling accuracy checks in the DHR. This deficiency was discussed during the inspection but not addressed in the firm's response.

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## Related Officers

- [Jennifer Hadfield](https://www.keypedia.com/people/jennifer-hadfield/104ee57e-26ee-445d-9887-857e0f798ffe)
- [Director](https://www.keypedia.com/people/raquel-peat/4631fa29-2503-4266-ab3b-4abf36d68a71)

Company: https://www.keypedia.com/companies/its-gmbh/222e9947-d8bf-4009-9811-979b8bd114c6

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