FDA 483 - CellRight Technologies LLC - July 25, 2024

CellRight Technologies LLC, a human tissue processor in Universal City, TX, received an FDA Form 483 citing significant deficiencies. The inspection revealed failures in validating manufacturing processes for skin graft products, inadequate testing of components, and non-adherence to procedures designed to prevent microbiological contamination. These observations indicate a lack of robust quality controls for their drug products.