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FDA Cracks Down on StemGenex for a Myriad of Issues

The San Diego-based biologic company was marketing an unapproved stem cell product manufactured in a questionable facility.

StemGenex Facility / Image: StemGenex
StemGenex Facility / Image: StemGenex

A recent FDA News Release brought to light some issues associated with San Diego’s StemGenex Biologic Laboratories LLC. Apparently the company was marketing an unapproved stem cell product and was in violation of good manufacturing practices. Investigators revealed 11 different violations at the firm’s facility including failures to follow procedures for preventing microbiological contamination of drug products purporting to be sterile.

StemGenex was also cited for not having a quality control unit since the beginning of 2012, and improper procedures for managing written and oral complaints. This is just the latest in the agency’s ongoing effort to crack down on producers of unapproved stem cell products.

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