Company: Rocky Mountain Lions Eye Bank
Product: Human corneas, sclera and whole eye globes
Date: 1/26/04
Paragraph 12 of the Biohazardous Waste Disposal procedure includes the provision that the Quality Assurance (QA) staff will review and verify the documentation of destroyed tissue on the Destruction Log is consistent with the record entry in the chart and the computer. The frequency of such QA review is not included in this procedure. Also, the procedure states that if variances are found, the technical staff and management will be informed to resolve the matter. The provision does not address how or if the findings of the QA staff will be documented nor how the variances will be presented to the technical staff and management. Our inspection revealed that your QA staff signed off on the discrepancies found in the Tissue Destruction Log noted above, although there is no indication that any corrective action was taken.
FDA District: Denver District Office
