Jogy George
Acting Division Director, Biologics Division II, Office of Biologics Inspectorate
OBI/OII, FDA (Silver Spring, MD)
Senior biologics inspection leader with 74 site inspections across 7 countries — leads complex, multi-day inspections of vaccine, blood product, and cellular therapy manufacturers with deep CBER expertise.
Inspection Approach
How Jogy Inspects
George brings a biologics-first lens to every inspection, informed by his role as Acting Division Director of the Office of Biologics Inspectorate Division II. His inspections centre on CBER-regulated products — vaccines, blood products, plasma derivatives, and cellular therapies — applying the specialised regulatory requirements of 21 CFR 600-680 that go beyond standard drug CGMP.
His progression from Regulatory Officer to Division Director means he leads complex, multi-day inspections of large biologics manufacturers, bringing a strategic perspective that evaluates not just individual compliance gaps but systemic quality system maturity. His prior experience as a manufacturing manager at Teva Netherlands gives him firsthand understanding of production operations, making him particularly effective at identifying process deviations that might escape desk-bound reviewers.
George's international inspection experience across 7 countries, including India and the United States, reflects comfort with multi-jurisdictional regulatory frameworks. He has participated in pre-license inspections (PLIs) and pre-approval inspections (PAIs) for biologics, where the stakes are highest and the regulatory scrutiny most intense.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Naari Pharma Private Limited
- Biologics manufacturing compliance deficiencies identified during CBER inspection
- Quality system gaps in deviation management and CAPA effectiveness
Speciality Pharma Manufacturing, LLC
- Manufacturing deficiencies at biologics/pharmaceutical facility
- Quality control and process validation gaps
Pre-Inspection Preparation
How to Prepare
- 1 Ensure all biologics manufacturing SOPs are current and personnel are trained on CBER-specific requirements — George applies biologics-specific CFR sections (600-680) beyond standard drug CGMP.
- 2 Validate aseptic processing with robust media fill studies that simulate worst-case conditions, including all routine and non-routine interventions.
- 3 Review environmental monitoring programmes for completeness — trending, alert/action limits, and thorough excursion investigations with organism identification.
- 4 Audit data integrity practices across QC laboratories — audit trails, electronic signatures, and access controls per 21 CFR Part 11.
- 5 Prepare thorough CAPA records with documented evidence of effectiveness checks — not just closure documentation.
- 6 Ensure supply chain qualification for biological starting materials is comprehensive and documented.
- 7 Review pre-license and pre-approval inspection readiness if any pending applications — George conducts PLIs and PAIs.
- 8 Have deviation investigation records readily accessible with root cause analyses supported by scientific evidence.
- 9 Validate cleaning procedures for multi-product biologics facilities with product-specific residue testing.
- 10 Prepare management for thorough, multi-day inspections — George's seniority means he leads complex team inspections.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
Download Jogy George — FDA Investigator Profile
Enter your details once to unlock all Audit Hub resources. All future downloads are instant.
Leucine is the first AI-native platform built for pharmaceutical manufacturing. It unifies quality management, regulatory compliance, and production operations into one intelligent system that powers your entire drug manufacturing lifecycle from raw materials to patient delivery.
