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# Eucyt Labs Warning Letter Over Cell Product
- URL: https://www.fdaweb.com/eucyt-labs-warning-letter-over-cell-product/
- Published: 2020-06-15T12:00:00.000Z
- Updated: 2026-09-14T16:18:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147000

FDA has issued a [Warning Letter ](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eucyt-laboratories-llc-607182-06042020?ref=fdaweb.com)to Eucyt Laboratories based on an inspection 11/2019 that cited the firm’s products, which are derived from human umbilical cord blood and umbilical cord, for use without agency approval. The letter said the products need approval to be promoted or used for treating arthritis or for cushioning joints. Additionally, during the inspection, FDA investigators documented GMP deviations. For example, the company failed to determine and document the eligibility of a cell or tissue donor based upon the results of donor screening and donor testing. It also failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes.