Jennifer L. Huntington
Consumer Safety Officer (Former)
ORA Florida District (Boca Raton, FL)
Prolific former FDA investigator with 68 483s and 10 warning letters across 8 countries — specialised in sterile compounding and outsourcing facility compliance, with an average inspection duration of 9.7 days.
Inspection Approach
How Jennifer Inspects
Huntington was one of FDA's most active sterile manufacturing investigators during her tenure (2015-2023), conducting approximately 86 inspections across 8 countries with a 483 issuance rate that reflects uncompromising standards for aseptic processing. Her primary focus was compounding pharmacies and 503B outsourcing facilities in the southeastern United States, where she consistently uncovered systemic sterility assurance failures.
Her inspection style is characterised by direct observation of production operations — she watches operators in real time and documents specific dates, times, batch numbers, and lot numbers of observed violations. At Westlab Pharmacy, she documented operators donning sterile gloves inside the ISO 5 hood (exposing hands to the critical zone), non-sterile wipes being used to clean LAFW before media fills, and uncovered light fixtures inside ISO 5 during production. These findings led to a recall of six lots and the firm ceasing high-risk sterile compounding.
Huntington pays particular attention to component handling and container closure integrity, stability testing programme completeness, and equipment surface conditions (rust, scratches, non-smooth surfaces in ISO 5 hoods). Her co-investigation with June P. Page at Sincerus Florida demonstrates how paired sterile manufacturing specialists can systematically dismantle a facility's quality system during a single inspection.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Westlab Pharmacy, Inc.
- Non-sterile wipes used to clean ISO 5 LAFW before media fill — contamination risk to sterility assurance
- Uncovered light fixtures inside ISO 5 LAFW during production of Dexamethasone and EDTA Ophthalmic products
- Operator donned sterile gloves inside the ISO 5 hood, exposing hands to the critical processing zone
- No written procedures for component identification, sampling, testing, approval, or rejection
- Use of non-pharmaceutical grade ingredients in compounding operations
- ISO 5 area not adjacent to ISO 7 room — facility design did not prevent contamination
- Resulted in recall of six lots (alprostadil, mitomycin, cyclosporine, ADAA) and cessation of high-risk sterile compounding
Sincerus Florida, LLC
- Hazardous drugs and antibiotics produced under the same hood as non-hazardous products — cross-contamination risk
- Powdered residue observed on equipment used in cream and emollient production
- Co-investigated with June P. Page
Pavilion Compounding Pharmacy
- Five observations documenting sterile compounding deficiencies
- Multiple aseptic processing failures identified during production observation
Maitland Labs of Central Florida
- Compounding/outsourcing facility violations leading to Warning Letter 610102 (August 2021)
- Persistent compliance failures at 503B facility
Infusion Systems of SW Florida (dba Myerlee)
- Sterile compounding deficiencies at infusion pharmacy
- Environmental monitoring and aseptic processing observations
Pre-Inspection Preparation
How to Prepare
- 1 Ensure all cleaning materials used in ISO 5 environments are sterile-grade — Huntington cited non-sterile wipes used to clean LAFW before media fills.
- 2 Verify that gloving and gowning occurs outside the critical processing zone — operators donning gloves inside ISO 5 hoods is a critical observation.
- 3 Inspect all light fixtures and non-flush surfaces inside ISO 5 enclosures — uncovered fixtures create contamination harbours.
- 4 Establish written procedures for component identification, sampling, testing, and approval/rejection — absence of these SOPs was a major finding.
- 5 Ensure pharmaceutical-grade ingredients are used for all compounding — non-pharmaceutical grade ingredients are a serious compliance failure.
- 6 Verify facility design places ISO 5 areas adjacent to ISO 7 areas with appropriate pressure cascades.
- 7 Separate hazardous drug production from non-hazardous operations — shared hoods between product types will be cited.
- 8 Review equipment surfaces for rust, scratches, and non-smooth areas — Huntington inspects ISO 5 hood surfaces for cleanability.
- 9 Ensure stability testing programmes include all scale-up batches with appropriate packaging configurations.
- 10 Prepare for extended inspections averaging 9.7 days — ensure documentation access and team availability for thorough review.
- 11 Review HPLC integration procedures and chromatographic data for proper peak integration parameters and scientific justification.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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