OsteoLife Biomedical I LLC — FDA Warning Letter Findings

In response to Observation 6, you stated that CAPA #001, “Quality Program Continuous Improvement and Enforcement” was initiated that includes drafting a new SOP on how to perform investigations detailing root cause analysis to be completed by April 2022. Your changes will be reviewed during the next inspection of your establishment to confirm compliance with 21 CFR 1271. You should take prompt action to correct the violations addressed in this letter and prevent their…

In response to Observations 4 and 5, you stated that “CAPA#002, Manufacturing monitoring to mitigate contamination” and “CAPA#003, Environmental monitoring” were initiated as corrective actions and that they would be completed by April 2022. Your changes will be reviewed during the next inspection of your establishment to confirm compliance with 21 CFR 1271.

In response to Observation 2, under paragraph 2(b) you stated you would, “Revalidate entire process for Processing of Flexo-Plate & Flexo-Membrane Grafts and Particulate Tissue.” We note that under 21 CFR 1271.230(a), process validation must be performed before manufacturing HCT/Ps. Your response does not indicate that you will halt processing of Flexo-Plate & Flexo-Membrane Grafts and Particulate Tissue products until your processes have been validated.

In your response to Observation 1, under paragraph 1(a), your revised SOP 110-006, Release of Processed Tissues states, “... in the event of a positive culture(s) the entire number of batches processed from the same donor during a processing session will be discarded.” Your response does not address your plan for the HCT/Ps you have already processed in violation of 21 CFR 1271 that have already been distributed, as well as the HCT/Ps that currently remain in storage.