FDA EIR - Natera Inc - November 08, 2018

An initial comprehensive surveillance inspection of Natera, Inc., located in San Carlos, CA, was conducted by the FDA from November 7-8, 2018. The inspection assessed the company's operations involving the recovery, screening, and labeling of umbilical cord blood stem cells for private donor banking. Natera, Inc. operates as a registered Human Tissue Establishment, with its activities governed by the Public Health Services Act, Section 361, and relevant sections of 21 CFR 1271 concerning Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).

Notably, no formal FDA Form 483 (Inspectional Observations) was issued during this inspection, indicating an absence of significant regulatory violations. However, two key discussion items were brought to the firm's attention: an incorrect suite number (Suite 410 instead of Suite 401) on the Evercord enrollment agreement, and a recommendation for conducting an additional shipping validation study under different environmental conditions, complementing existing studies. Natera, Inc.'s management acknowledged these points and committed to implementing the necessary corrections and performing the additional temperature shipping validation studies as discussed. The report also confirmed no reported illnesses, adverse reactions, or injury complaints.