OsteoLife Biomedical I 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 process HCT/Ps in a way that does not cause contamination or cross-contamination during processing and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P [21 CFR 1271.220(a)]. Specifically:

Passage 2

Failure to validate and approve processes according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests [21 CFR 1271.230(a)]. For example:

Passage 3

Failure to monitor environmental conditions where they could reasonably be expected to cause contamination or cross contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents [21 CFR 1271.195(c)]. For example:

Passage 4

Failure to investigate HCT/P deviations and trends of HCT/P deviations relating to core CGTP requirements. Under the applicable regulation, each investigation must include a review and evaluation of the HCT/P deviation, the efforts made to determine the cause, and the implementation of corrective action(s) to address the HCT/P deviation and prevent recurrence [21 CFR 1271.160(b)(6)]. Specifically: