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# QS Violations at IsoTis OrthoBiologics
- URL: https://www.fdaweb.com/qs-violations-at-isotis-orthobiologics/
- Published: 2026-03-24T12:00:00.000Z
- Updated: 2026-09-14T13:36:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160864

A 10/6-10/17/2025 FDA inspection at the IsoTis OrthoBiologics facility in Irvine, CA, found Quality System Regulation violations in the firm’s manufacturing of resorbable calcium salt bone void filler devices branded under the Accell family of products. A just-released 2/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isotis-orthobiologics-inc-723370-02242026?ref=fdaweb.com) says the specific violations were:

- failure to adequately establish procedures for corrective and preventive action;
- failure to revalidate a validated process when changes or process deviations occurred; and
- failure to establish an adequate risk analysis.

IsoTis was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.