FDA 483 - Biocore9 Llc - November 06, 2023

An FDA inspection of Biocore9 LLc, a specification developer in Whippany, NJ, revealed significant deficiencies in its quality system related to the manufacture of sterile humeral and femoral head resurfacing systems. The firm failed to adequately validate sterilization processes, perform complete risk analyses, qualify suppliers, and establish proper design controls. Additionally, issues were noted with non-conforming product procedures, management review, internal audits, and medical device reporting.