FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Stem Cell Facility Warned for ‘Objectionable Conditions’

Nov. 21, 2018

The FDA sent a warning letter listing a slew of violations to StemGenex Biologic Laboratories, following a January 16-26 inspection of its San Diego, California, facility.

The stem cell clinic was called out for “significant objectionable conditions” related to current good manufacturing practices. Among them: failing to perform media fill simulations to evaluate the aseptic process used for manufacturing batches of its stromal vascular fraction (SVF) product, which is supposed to be sterile.

The firm also didn’t conduct routine personnel monitoring and qualification checks of individuals who aseptically manufactured the SVF product.

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