Lori M. Newman
Consumer Safety Officer, DVM
ORA New England Region (Greater Boston)
Veterinary medicine-trained investigator specialising in sterile manufacturing and 503B outsourcing facility compliance — with a keen eye for facility construction defects and a higher-than-average warning letter conversion rate.
Inspection Approach
How Lori Inspects
Newman's DVM background gives her a unique scientific perspective on microbiological contamination risks that distinguishes her from other investigators. She brings meticulous attention to sterilisation documentation, equipment calibration records, and — distinctively — facility construction issues that may compromise sterile operations.
Her inspection style is characterised by systematic review of aseptic processing areas, with particular attention to sterilisation process validation and container closure integrity. At Fresenius Kabi Compounding, she identified that defective IV bags with detectable port defects were being used despite quality control procedures that should have caught them. At Cipla, working with Sean Marcsisin, she uncovered that approximately 177 of 229 investigation emails were missing from servers and that root cause conclusions were being modified in TrackWise without documented justification.
Newman has a notable track record with 503B outsourcing facilities — her inspections at SterRx and US Specialty Formulations both resulted in warning letters. She rigorously checks whether bulk drug substances come from registered establishments and whether labeling meets all 503B requirements, including the "This is a compounded drug" statement.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
SterRx, LLC
- Outsourcing facility (503B) sterile compounding deficiencies
- Labeling failures — missing "This is a compounded drug" statements, phone number, NDC, and storage instructions
US Specialty Formulations LLC
- Outsourcing facility using bulk drug substances not manufactured by registered establishments
- 503B compliance failures in drug substance sourcing and quality oversight
Zydus Lifesciences Limited
- Joint inspection with Marcsisin — process validation and visual inspection training deficiencies
- Injectable product quality concerns identified across manufacturing operations
Cipla Limited
- Global Quality Investigation team making undocumented changes to investigations via email
- Approximately 177 of 229 CQN investigation emails missing from company servers
- Root cause changes not documented in TrackWise — conclusions modified without audit trail
- "Sample bias" OOS conclusions lacking any scientific rationale
Fresenius Kabi Compounding, LLC
- Defective IV bags with detectable port defects used despite quality control procedures
- Quality control unit procedures not followed for CSP defect review
- Failure to review compounded sterile preparation defects before release
Pre-Inspection Preparation
How to Prepare
- 1 Conduct thorough review of all aseptic processing area qualifications and ongoing monitoring data.
- 2 Ensure sterilisation process validation is current with documented cycle development studies.
- 3 Verify all critical equipment calibration records are current and traceable to NIST standards.
- 4 Inspect facility construction for cracks, gaps, unsealed penetrations, or difficult-to-clean surfaces — Newman specifically looks for construction defects.
- 5 Review environmental monitoring programme for completeness of sampling locations, frequencies, and trend analysis.
- 6 Ensure document management system captures all investigation changes with full audit trails — no modifications via email.
- 7 For 503B outsourcing facilities: verify all bulk drug substances come from registered establishments per Section 510.
- 8 Ensure container labels include all required 503B information — adverse event reporting contact, directions for use, compounding statement.
- 9 Have cleaning validation protocols that reflect actual manufacturing conditions and worst-case scenarios.
- 10 Review IV bag and container closure integrity testing programmes if manufacturing sterile solutions.
- 11 Prepare for scrutiny of quality unit procedures — Newman checks whether QC/QA procedures are actually followed, not just documented.
- 12 Ensure investigation records in validated systems reflect ALL reviews and changes, not just final conclusions.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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