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# Advita Ortho Hit with 7 QS Violations
- URL: https://www.fdaweb.com/advita-ortho-hit-with-7-qs-violations/
- Published: 2026-03-11T12:00:00.000Z
- Updated: 2026-09-14T13:35:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160800

A 715-7/25/2025 FDA inspection at the Exactech Inc. facility in Sarasota, FL, doing business as Advita Ortho, identified seven Quality System Regulation violations in the firm’s manufacturing of accessories for the Equinoxe Reverse Shoulder System. A just-released 12/19/2025 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/exactech-inc-dba-advita-ortho-720250-12192025?ref=fdaweb.com) says the specific violations were:

- failure to establish and maintain process control procedures describing any process controls necessary to ensure conformance to specifications when deviations from device specifications could occur as a result of the manufacturing process;
- failure to adequately establish and maintain procedures for corrective and preventive action;
- failure to adequately establish and maintain procedures to control product that does not conform to specified requirements;
- failure to adequately establish and maintain procedures to ensure that environmental conditions do not adversely affect product quality;
- failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
- failure to adequately establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities; and
- failure to adequately establish procedures for acceptance activities.

FDA says some of the firm’s responses to the inspection observations are inadequate or their adequacy could not be determined. Advita was told to correct the violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation of each action and a schedule for completing the corrections.