Safari Stem Cell, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity that they purport or are represented to possess [21 CFR 211.100(a)]. You have not established written procedures that describe the manufacture of stem cells from umbilical cord and bone marrow.

Passage 2

Failure to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms [21 CFR 211.165(b)]. Specifically, you failed to perform appropriate laboratory testing, including sterility testing, on at least **(b)(4)** batches of the stem cell products derived from adipose tissue, umbilical cord, and bone marrow which are administered intravenously or intrathecally.

Passage 3

Failure to have a system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. Specifically, your firm has not established a system for environmental monitoring in the aseptic processing area where stem cell products derived from adipose tissue, umbilical cord, and bone marrow are manufactured.

Passage 4

Failure to establish and follow written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product [21 CFR 211.67(b)]. You do not have written cleaning procedures for the manufacturing of your culture expanded allogeneic adipose-derived animal cell product. Furthermore, your firm does not keep cleaning records, as required by 21 CFR 211.67(c).

Passage 5

Failure to establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)] (see also 21 CFR 211.180(e)(2)). Our investigation found that you do not have written procedures for handling or investigating complaints.