FDA EIR - Sightlife - October 13, 2017

An FDA inspection of Sightlife, a human tissue establishment in Seattle, WA (FEI: 3001239136), was conducted from October 10-13, 2017. The inspection, carried out under regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) as outlined in 21 CFR Part 1271, identified two primary concerns. Firstly, facilities were not maintained in a good state of repair, specifically a broken light cover was observed in the modular laboratory above a tissue processing station. This was especially concerning given that ceiling cleaning had not been documented for over a year, and five MedWatch reports since May 2016 indicated Candida contamination in tissues processed in that laboratory. Management committed to replacing the light cover, cleaning the affected area, and updating cleaning documentation. Secondly, documentation accompanying distributed ocular tissues did not explicitly state whether the donor was determined to be eligible or ineligible, an issue that had been discussed in a previous inspection. Management disagreed with the regulatory interpretation but noted they had previously requested a software change to address this. The inspector suggested a simpler interim solution. Additionally, a general discussion highlighted the need for the firm's records to include an interpretation of communicable disease test results, not just a list of raw data. Sightlife committed to making these changes but sought further clarification on the regulatory interpretation. A Form FDA 483 was issued, requiring a written response from the company addressing these observations.