Simleen Kaur
Captain, USPHS; Team Leader, Laboratory of Microbiology, CBER
CBER Office of Compliance and Biologics Quality (Silver Spring, MD)
CBER microbiological testing specialist who participates in biologics inspections as a subject matter expert — focused on microbial test method validation, potency testing, and environmental monitoring at vaccine and gene therapy manufacturers.
Inspection Approach
How Simleen Inspects
Kaur brings deep microbiological expertise to biologics inspections as a CBER subject matter expert, rather than a traditional ORA field investigator. Her participation in inspections centres on evaluating whether microbiological test methods are validated per CFR and pharmacopeial requirements (USP, EP, JP), and whether potency testing procedures are accurate and traceable to appropriate reference standards.
Her inspection portfolio includes major biologics manufacturers — BioMarin Pharmaceutical (rare disease drugs), Sarepta Therapeutics (gene therapy for Duchenne muscular dystrophy), GlaxoSmithKline Biologicals (vaccines), and Celltrion (biosimilars). At each facility, she evaluates contamination control strategies specific to biological products, environmental monitoring programmes, and sterility assurance procedures.
As a Captain in the U.S. Public Health Service Commissioned Corps and Team Leader of the Laboratory of Microbiology In-vivo Testing and Standards at CBER, she manages CBER reference standard production — giving her unique insight into whether facilities are properly using these standards in their potency testing programmes.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
BioMarin Pharmaceutical Inc.
- Biologics manufacturing compliance deficiencies at rare disease drug facility
- Microbiological testing and quality system observations identified
Sarepta Therapeutics, Inc.
- Gene therapy manufacturing inspection — ELEVIDYS (SRP-9001) for Duchenne muscular dystrophy
- Compliance observations related to biologics manufacturing standards
GlaxoSmithKline Biologicals SA
- Major vaccine manufacturer inspection — CBER compliance review
- Observations on microbiological testing and process control procedures
Pre-Inspection Preparation
How to Prepare
- 1 Ensure all microbiological test methods are fully validated per USP <61>, <62>, <71>, and applicable pharmacopeial standards.
- 2 Validate rapid microbial methods with documented equivalency studies if replacing traditional compendial methods.
- 3 Maintain comprehensive environmental monitoring programmes with trending, alert/action limits, and thorough excursion investigations.
- 4 Verify potency testing methods are validated and traceable to appropriate reference standards, including CBER reference materials.
- 5 Document contamination control strategy with risk assessments specific to biologics product types.
- 6 Ensure sterility assurance programmes are robust for aseptic processing of biologics, including media fills and bioburden testing.
- 7 Review data integrity practices in microbiology and QC laboratories — audit trails, electronic records, access controls.
- 8 Prepare documentation showing compliance with BLA commitments for test methods and specifications.
- 9 Verify all SOPs for microbiology testing are current, approved, and demonstrably followed by trained personnel.
- 10 Have trending data available for environmental monitoring, bioburden, and sterility testing over meaningful time periods.
- 11 Review any changes to microbial methods with comparability/equivalency data to demonstrate method suitability.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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