FDA 483 - Hybrid Pharma LLC - November 09, 2023

An FDA inspection of Hybrid Pharma LLC, an outsourcing facility in Deerfield Beach, FL, revealed significant deficiencies in aseptic processing, laboratory controls, and record-keeping. Observations included contaminated HEPA filters, inadequate media fill simulations, unvalidated test methods, and the compounding of drug substances on the Category 2 list. Many of these issues were repeat observations from previous inspections, indicating persistent non-compliance.