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# QS Issues at TEI Biosciences
- URL: https://www.fdaweb.com/qs-issues-at-tei-biosciences/
- Published: 2019-03-19T12:00:00.000Z
- Updated: 2026-09-15T01:13:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143641

A 10/9-11/2/18 FDA inspection at Integra LifeSciences’ TEI Biosciences unit in Boston, MA, found Quality System Regulation violations in the firm’s manufacturing of collagen-based medical devices used for wound care, soft tissue repair, and reconstruction therapy. A 3/6 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm633145.htm?ref=fdaweb.com) says the specific violations were: 

- failing to validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection and test;
- failing to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality;
- failing to establish and maintain procedures to adequately control environmental conditions where environmental conditions could reasonably be expected to have an adverse effect on product quality; and
- failing to establish and maintain procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.

The letter says the firm’s responses to the inspection observations were inadequate. TEI was told to respond with a list of steps it has taken to correct the violations and prevent their recurrence, with documentation of each correction and a timetable for completion.