Muna Algharibeh
Consumer Safety Officer / Investigator
ORA Indianapolis Resident Post
Sterile manufacturing specialist who scrutinises media fill completeness, personnel qualification breadth, and particle contamination investigations — with notable inspections at Catalent, Eli Lilly, and Panacea Biotec.
Inspection Approach
How Muna Inspects
Algharibeh focuses almost exclusively on sterile drug and biologics manufacturing, bringing particular intensity to the evaluation of media fill simulations and personnel qualification programmes. Her approach is distinguished by a demand for completeness — she expects media fills to simulate ALL routine and non-routine interventions, and she expects ALL personnel who enter aseptic areas to be formally qualified, including engineers, supervisors, and QA staff, not just production operators.
At Catalent Indiana, she pursued 179 particle-related complaints and 52 stopper-related supplier complaints that had been inadequately investigated, demonstrating a willingness to dig into complaint files and trace systemic quality failures. At Panacea Biotec in India, she documented peeling tapes in RABS, undocumented personnel activities during media fills, and inadequate NVPC monitoring probe placement.
Her documentation style is precise and evidence-based — she identifies specific gaps between what the quality system documents and what actually happens during manufacturing, particularly around who performs what activity and whether those activities are covered by existing qualifications and validation studies.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Catalent Indiana, LLC
- 179 particle-related complaints inadequately investigated — no root cause identification
- 52 stopper-related supplier complaints without adequate investigation or trending
- Fibre removal during aseptic filling observed without investigation of the fibre source
- Inadequate assessment of cleaning procedures for impact on subsequent batches
Panacea Biotec Pharma Limited
- Peeling tapes used in RABS barriers — compromising aseptic environment integrity
- Second operator entering LAF area not addressed in media fill simulation studies
- Undocumented personnel activities during media fill — who did what was not traceable
- Inadequate NVPC monitoring with improper probe placement relative to process risk
- Engineers, supervisors, and IPQA personnel not qualified for aseptic area entry despite routine access
- 9-observation Form 483 resulting in subsequent warning letter
Eli Lilly and Company
- Major biologics/drugs facility inspection with team of 4 investigators
- Co-investigators: Robert J. Ham, Sandra A. Boyd, Rafeeq A. Habeeb
Ceela Naturals
- Manufacturing and quality system deficiencies at natural products facility
Caldic USA Inc
- Drug manufacturing compliance deficiencies identified during routine inspection
Pre-Inspection Preparation
How to Prepare
- 1 Validate media fill studies to include ALL routine and non-routine interventions — Algharibeh specifically cites incomplete simulations that miss real-world activities.
- 2 Ensure all personnel entering aseptic areas are formally qualified — including engineers, supervisors, and QA staff, not just production operators.
- 3 Document individual roles and activities during media fills — who performed what must be traceable to qualified individuals.
- 4 Audit NVPC monitoring: verify probe placement matches process risk, verify trending is adequate, and ensure excursion investigations are thorough.
- 5 Review RABS/isolator integrity — check for peeling tapes, degraded materials, or compromised barrier integrity that could affect sterility assurance.
- 6 Investigate all particle-related and foreign material complaints thoroughly with root cause identification — 179 unresolved complaints will draw intensive scrutiny.
- 7 Maintain complete supplier complaint files for container closure components (stoppers, vials) with trending analysis.
- 8 Ensure cleaning procedures are validated and assessed for impact on subsequent batches when changes occur.
- 9 Prepare thorough change management records — Algharibeh scrutinises change control processes for completeness.
- 10 Verify environmental monitoring alert/action limits are scientifically justified and excursions trigger documented CAPA.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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