I.T.S. GmbH – FDA Warning Letter, Jan 19, 2023

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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