FDA WARNING_LETTER - Balin, Martin S., MD, PhD - August 17, 2012

An FDA inspection of Martin S. Balin, MD, PhD, located at 2825 N. Halsted St., Chicago, Illinois, was conducted from June 20, 2012, through August 17, 2012. The inspection revealed significant deviations from regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271.

Key violations include: 1. Failure to test reproductive donors for Chlamydia trachomatis and Neisseria gonorrhea (21 CFR 1271.85(c)), with four specific donor examples cited where eligibility was determined despite missing test results. 2. Failure to test reproductive donors for HIV-1 and HCV by NAT method (21 CFR 1271.85(a)), citing three donor examples. 3. Failure to use FDA-licensed, approved, or cleared donor screening tests, lacking documentation for test kits used by LifeSource Testing Laboratory and HealthLab (21 CFR 1271.80(c)). 4. Failure to determine donor eligibility *after* receiving all communicable disease testing results (21 CFR 1271.50(a)), with three donor examples where eligibility was determined prematurely. 5. Failure to screen donors by reviewing relevant medical records, specifically lacking documentation of physical examinations