Suspended California cell therapy manufacturing site hit with FDA warning letter over major quality concerns
A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.
The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”
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