Jeffrey P. Raimondi
Consumer Safety Officer
ORA Los Angeles District
Exceptionally broad international inspector with 90 site inspections across 12 countries — covers drug manufacturers, API producers, and cosmetics/drug hybrid facilities with deep focus on aseptic processing and laboratory controls.
Inspection Approach
How Jeffrey Inspects
Raimondi is among the most geographically prolific FDA investigators, with inspections spanning 12 countries across Asia, Europe, and North America. His breadth extends beyond geography to product type — he inspects finished dosage form manufacturers, API producers, and cosmetics/drug hybrid facilities with equal rigour, applying CGMP requirements regardless of the product classification.
His inspection approach emphasises laboratory controls and aseptic processing. He scrutinises smoke studies for evidence of first-air protection, examines gowning procedures for exposed skin in aseptic zones (citing goggles with open holes at one facility), and reviews media fill adequacy. He pays particular attention to the completeness of stability programmes and whether OOS investigation procedures include documented root cause analysis.
Raimondi's work at Hetero Labs in India, which led to a subsequent warning letter, demonstrates his ability to identify systemic quality failures at large international manufacturers. His co-investigation network includes investigators across multiple districts, reflecting his role in complex team inspections at high-priority foreign facilities.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Hetero Labs Limited
- Multi-system CGMP deficiencies identified during team inspection
- Findings escalated to warning letter following inadequate response
- Co-investigators: Guerlain Ulysse, Rita K. Kabaso
COSMECCA KOREA CO., LTD
- Cosmetics/drug hybrid facility inspection — CGMP applied to all drug-claim products
- Manufacturing controls and quality system deficiencies at cosmetics manufacturer
Vege Labs LLC
- Drug manufacturing compliance deficiencies identified during domestic inspection
Creative Essences Inc.
- Quality system and manufacturing controls deficiencies at drug/cosmetics facility
Pre-Inspection Preparation
How to Prepare
- 1 Review all CGMP documentation for completeness and currency — Raimondi inspects across drug types and product categories and will look broadly.
- 2 Validate aseptic processing procedures including smoke studies demonstrating first-air protection and unidirectional airflow.
- 3 Ensure gowning procedures are validated and operators have no exposed skin in aseptic zones — he has cited goggles with open holes.
- 4 Prepare robust OOS investigation procedures with documented, scientifically sound root cause analysis.
- 5 Audit stability programmes for protocol adherence and proper use of results in expiry dating decisions.
- 6 If manufacturing cosmetics with drug claims, ensure full CGMP compliance — Raimondi inspects these facilities under drug CGMP standards.
- 7 Ensure warehouse and storage areas have proper environmental controls with continuous temperature and humidity monitoring.
- 8 Review API supplier qualification and incoming material testing — especially identity testing per 21 CFR 211.84.
- 9 Prepare for unannounced or short-notice foreign inspections — Raimondi conducts international inspections across 12 countries.
- 10 Ensure laboratory test methods are validated with documented accuracy, sensitivity, specificity, and reproducibility.
- 11 Review cleaning validation records and cross-contamination prevention measures for shared equipment lines.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
Download Jeffrey P. Raimondi — 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.
