Renovis Surgical Warned Over Quality System Violations
Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis.
The Redlands, Calif.-based company is an original equipment manufacturer of spinal implants, hip and knee replacements and surgical instruments.
The May 5 warning letter cites the OEM for failing to confirm that design output meets design input requirements during design verification.
The firm’s titanium stand-alone anterior lumbar fusion cage did not contain documentation to support the firm’s design verification conclusions.
Specifically, there was no documentation to confirm that the contract manufacturer performed validation activities, and documentation covering sterilization validation was inadequate.
The warning letter notes similar examples of failure to document testing to confirm that design outputs met design inputs.
Risk analysis was also found lacking for the lumbar device because the firm did not reference cleaning and sterilization validation studies even though the design history file requires risk activities due to potential risk of infection.
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