After a couple of busy weeks, this is a slow one. FDA did post and then removed one to a device manufacture who also functioned as a contract sterilizing service. I’m sure we will see this again next week.
Enforcement includes one untitled letter and one warning letter to cell therapy companies. This represents FDA’s ongoing concerns about these product type.
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CELL AND TISSUE THERAPIES | Chara Biologics Inc.
Chara Biologics Inc. (Woodland Hills, CA) received an untitled letter on November 25, 2019 based on a review of their website. The firm makes drug-like claims for their non-homologous tissue therapy products, particularly the treatment of autism. FDA points out that this product is subject to additional oversight including premarket review.
CELL AND TISSUE THERAPIES | Liveyon Labs Inc.
Liveyon Labs Inc. (Yorba Linda, CA) received a warning letter on December 5, 2019 based on the outcome of an inspection ending May 23, 2019. The firm processes human umbilical cord blood-derived cellular products.
The firm’s products do not qualify for any exception in 21 CFR 1271.15. The products are not meant solely for autologous use but are for allogeneic use. FDA also determined that the information on the company website identified that these products are meant to treat a variety of medical conditions. There is no IND in place. The form 483 at the end of the inspection was issued to the chief compliance officer for both Liveyon Labs and Liveyon LLC. Only the first and second warning letter deficiencies were cited against 21 CFR 1271, the remaining were cited against 21 CFR 211.
While the firm responded to the warning letter they failed to address their lack of an IND. Other responses did not include sufficient detail to be able to address them adequately.
The deficiencies in the warning letter include but are not limited to:
- The firm did not screen donor tissues by reviewing relevant medical records or performing appropriate tests. The firm did not review medical records to determine if the donor may have risk factors or clinical evidence of infection by Zika virus, nor did they assess donors for a diagnosis of CJD infection or vCJD infection.
- The test for Zika virus was performed using a test that had not been licensed by FDA.
- The firm’s aseptic processing was not validated, gowning procedures are not adequate or implemented, and the components used in aseptic processing were labeled as “for research use only.”
- The firm failed to investigate sterility failures; the warning letter identifies fifteen that occurred between January 2019 and May 2019. The lots were destroyed prior to conducting investigations of the reason for the sterility failures. No corrective or preventive actions were put in place. In addition, the firm failed to investigate five in-process settle plate failures. Although the organisms were identified, there was no investigation of the root cause and source of the organisms.
- Environmental Monitoring was inadequate, including reporting of microbiological data. CFU/mL greater than 1 was simply identified as “1+”, and occasionally the 1+ was incorrectly identified as 1 CFU/mL.
- Cleaning validation did not address efficacy of cleaning agents.
- Components were not tested before release for use in manufacture.
- Complaint procedures were not followed and were not adequate.
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