Orthopedic Alliance LLC – FDA Warning Letter, Sep 23, 2011

On February 3, 2012, the FDA issued a Warning Letter to Orthopedic Alliance following an inspection from July 20 to September 23, 2011. The inspection found that the firm's orthopedic implant devices, including the SC Total Hip System and SC Ceramic Ball Heads, were adulterated under Section 501(h) of the Act, as manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)). The firm's response, citing employee training and a 60-day implementation, was deemed inadequate due to lack of submitted procedures or rationale for the delay. 2. Failure to establish and maintain procedures for complaint handling (21 CFR 820.198(a)). The firm's response, stating development with the MDR program within 30-60 days, was inadequate as no procedures were submitted, nor was a rationale for the timeframe provided. 3. Failure to establish and maintain adequate procedures for finished device control and distribution (21 CFR 820.160(a)), specifically regarding incomplete distribution records. The firm's response about a new tracking procedure was inadequate as no procedure was provided or evidence of