FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Tennessee Firm Hit for Inadequate Procedures

Sept. 19, 2019
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Design verification and validation procedures were found to be lax during an FDA inspection at Stetrix’s Bartlett, Tennessee facility.

The design inputs for the Class II Hem-Avert peri-anal stabilizer were not adequately documented, and they didn’t address requirements for physical and performance characteristics, sterility shelf life, labeling or packaging, and design inputs were not reviewed and approved by a designated person, the agency said.

The specification developer also failed to document in the design history file that design output met design input requirements, according to the Form 483.

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