Sean R. Marcsisin
Senior Consumer Safety Officer, Ph.D., LCDR USPHS
ORA New England Region (Stoneham, MA)
Contamination control and aseptic processing expert with 81 site inspections across 12 countries — known PDA speaker on inspection preparation who combines chemistry PhD expertise with deep focus on sterile manufacturing and process validation.
Inspection Approach
How Sean Inspects
Marcsisin brings a scientist's rigour to sterile manufacturing inspections, informed by his PhD in Chemistry from Northeastern University and his experience as a PDA speaker on FDA inspection preparation and pre-approval inspection trends. His primary focus is contamination control — consistently the top citation area across his inspections — followed by environmental monitoring and quality risk management.
At Zydus Lifesciences, he identified that process performance qualification (PPQ) studies lacked inter- and intra-batch variability evaluation, and that visual inspection training for glass particle detection was deficient below threshold. At Cipla, working alongside Lori Newman, he uncovered that the Global Quality Investigation (GQI) team was making undocumented changes to investigations via email rather than within the validated TrackWise system.
His inspection portfolio spans pharmaceutical manufacturers, biologics facilities, and compounding pharmacies (both 503A and 503B), giving him broad perspective on sterile manufacturing compliance across facility types. He frequently co-investigates with Lori Newman, creating a pairing that covers contamination control expertise (Marcsisin) and sterilisation/facility design scrutiny (Newman).
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Zydus Lifesciences Limited
- PPQ studies lacked inter- and intra-batch variability evaluation — acceptance criteria not scientifically defined
- Visual inspection training deficient for glass particle detection below threshold specifications
- Line stoppage exposure time during aseptic filling not validated
Cipla Limited
- Global Quality Investigation (GQI) team making undocumented changes to investigations via email
- Approximately 177 of 229 CQN investigation emails missing from servers
- Root cause changes in TrackWise not documented — final conclusions modified without audit trail
- "Sample bias" OOS conclusions lacking scientific rationale or supporting data
Novo Nordisk US Bio Production Inc.
- Contamination control deficiencies at biologics manufacturing facility
- Environmental monitoring programme gaps identified during inspection
ONY Biotech Inc.
- Biologics/drug manufacturing deficiencies at production facility
Pre-Inspection Preparation
How to Prepare
- 1 Ensure contamination control strategy is comprehensive, documented, and evidence-based — this is Marcsisin's primary focus area across all inspections.
- 2 Validate environmental monitoring programmes with clear action/alert limits and statistical trend analysis over meaningful time periods.
- 3 Review process validation (PPQ) studies for inter- and intra-batch variability acceptance criteria — vague or undefined criteria will be cited.
- 4 Verify training records demonstrate competency, especially for visual inspectors — he checks that training covers particle detection below threshold.
- 5 Have cleaning validation studies current and scientifically justified, especially for shared equipment.
- 6 Ensure quality risk management documentation (ICH Q9) is applied to contamination control decisions.
- 7 Document all sterile product exposure times and validate hold-time studies at commercial scale.
- 8 Prepare for deep-dive review of aseptic processing simulations (media fills) — ensure all interventions are simulated.
- 9 Ensure investigation records in validated systems (TrackWise, etc.) capture ALL reviews and changes — not via email.
- 10 Verify that "sample bias" or "equipment glitch" OOS conclusions are supported by documented scientific rationale.
- 11 Review line stoppage procedures during aseptic filling — ensure exposure time limits are validated and documented.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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