FDA EIR - SciSafe, Inc. - October 17, 2018

The FDA conducted a routine inspection of SciSafe, Inc. in Cranbury, NJ, on October 17, 2018. This comprehensive inspection focused on Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/P) activities, specifically the storage of umbilical cord blood stem cells and the storage and distribution of amniotic membrane/fluid products. The review was performed under Compliance Program 7341.002, which governs HCT/P inspections. During the assessment, inspectors examined the company's policies, procedures, inventory records, product traceability, freezer qualifications, data logging, and equipment maintenance. The facility was noted to be clean, organized, and properly equipped for its operations. However, two primary deficiencies were identified: SciSafe, Inc. did not possess a written procedure for the quarantine and recall of HCT/P products, nor did it have a written procedure for the return of such products to inventory. These observations were communicated verbally to the company's President and owner, Mr. Garrie E. Richardson, and did not result in the issuance of an FDA Form 483. The main required actions for SciSafe, Inc. are to establish and implement these missing written procedures for the quarantine, recall, and return-to-inventory processes for HCT/P products to ensure robust regulatory compliance.