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# QS Violations at TEI Biosciences
- URL: https://www.fdaweb.com/qs-violations-at-tei-biosciences/
- Published: 2023-08-15T12:00:00.000Z
- Updated: 2026-09-14T18:50:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155098

A 3/1-5/17 FDA inspection at TEI Biosciences in Boston, MA, an Integra LifeSciences company, found Quality System (QS) regulation violations in the firm’s manufacturing of collagen-based medical devices, such as Durepair, used for wound care, soft tissue repair, and reconstruction surgery. A just-released 7/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/integra-lifesciences-corporation-660960-07172023?ref=fdaweb.com) says specific violations were:

- failing to establish and maintain procedures to control product that does not conform to specified requirements;
- failing to establish and maintain procedures for implementing corrective and preventive actions, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems;
- failing to validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test; and
- failing to store devices in a manner to facilitate proper stock rotation and to assure their condition as appropriate.

FDA says it confirmed on 5/23 that TEI had initiated a recall of all finished goods manufactured within expiry from 3/1/2018 through 5/22/2023\. It also says it understands that TEI has committed to not distributing product until the site is operating in substantial conformity with QS regulations. The letter says the company’s responses to the inspection observations were not adequate.

TEI was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections or corrective actions, and a schedule for completing the work. It also is to submit a certification by an outside consultant that he or she has audited the establishment’s manufacturing and quality assurance systems relative to QS regulations and certification by the company CEO that the consultant’s report has been reviewed and that TEI has initiated or completed all recommendations in the report.