GDF2026 - Common Microbiology Deficiencies for Ophthalmic Suspension Drug Products
Office of Pharmaceutical Quality presentation · July 30, 2026
Arlene Chen of OPQ presented an FDA overview of common microbiology deficiencies in ophthalmic suspension ANDA submissions, highlighting findings from 108 microbiology information requests and detailing problems with sterilization validation, container-closure integrity, preservative testing, bioburden measurement, media fills and requalification needs.
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