Back to: FDA Generic Drugs Forum 2025
Presenter
Andrew Idzior
Chemist
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Andrew Idzior currently performs manufacturing process and facility assessment of CMC sections for drug applications. As a prior FDA investigator, Andrew Idzior led cGMP and pre-approval inspections of drug manufacturing facilities. Additionally, Andrew Idzior performed and developed analytical chemistry test methods for drug samples as an FDA regulatory chemist.
Abstract
At the 2025 Generic Drugs Forum, Andrew Idzior, a chemist with the FDA’s Office of Pharmaceutical Manufacturing Assessment, presents data on common manufacturing process and facility deficiencies that led to major complete response letters (CRLs) for abbreviated new drug applications (ANDAs) in fiscal year 2023. The focus is on deficiencies tied to first-cycle major withhold recommendations. Analysis revealed that while only seven ANDAs received major process deficiencies, all involved liquid parenteral products, commonly due to issues like scale-up batch needs and process-related leachables (PERLs). Eighteen ANDAs received major facility deficiencies—split evenly between solid and liquid forms—primarily stemming from inadequate pre-approval inspections. Key facility-related issues included unqualified equipment, inadequate microbiological controls, and insufficient manufacturing data. The presentation highlights the importance of FDA guidance documents and emphasizes that while first-cycle approvals are improving, significant deficiencies remain a major barrier to timely ANDA approval.