June P. Page
Investigator
ORA New Orleans District (Nashville, TN)
Sterile compounding and aseptic processing specialist with a track record of inspections at outsourcing pharmacies — known for testing QA reviewers' actual knowledge and documenting months-long delays in deviation initiation.
Inspection Approach
How June Inspects
Page approaches inspections with a focus on the operational reality of sterile manufacturing, particularly at compounding pharmacies and outsourcing facilities. She begins by evaluating environmental monitoring programmes — checking whether air sampling, surface monitoring, and viable particle counts are performed during dynamic production conditions, not just during periodic recertifications.
A defining characteristic of her inspection style is directly interviewing QA and QC reviewers to assess whether they understand what they are signing off on. At Wells Pharmacy Network, she documented pharmacists who stated they "did not know what they were reviewing" and a Head of QA who admitted they only checked that paperwork was filled out, not the accuracy of the data. This pattern of testing personnel competency through targeted interviews appears across multiple inspections.
Page also meticulously tracks the timeline between when an event occurs and when a deviation or corrective action is initiated. She has documented delays of 8–9 months at multiple facilities, and physically observes production operations to cross-reference batch records against what actually happens on the floor — catching broken tools, undocumented incidents, and gowning failures that never made it into the quality system.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Bond Pharmacy, Inc. dba Advanced Infusion Solutions
- Colony growth in ISO 5/7/8 areas from July–October 2015 with no adequate investigation or corrective action
- Surface and air monitoring of ISO 5 environment not performed daily during sterile drug production
- 483 response deemed partially deficient by FDA, leading to Warning Letter #497408
Wells Pharmacy Network LLC
- Media fills for personnel qualification were inadequate for the operations performed
- TNTC (too numerous to count) colony growth plate found with no investigation or trending conducted
- Non-dedicated tablet press not adequately cleaned between batches of different products
- Cracked balance glass creating contamination potential in weigh area
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
- Air sampling not performed during dynamic conditions during cleanroom recertifications
- No continuous or periodic monitoring of air pressure differentials between classified areas
- Personnel did not sterilise vial crimper before placing in laminar flow hood (ISO 5)
- Sub-potency failure for HCG 5000IU — lot released and dispensed to patients despite OOS result
Wells Pharmacy Network LLC
- 9-month delay in initiating corrective actions for a personnel incident (May 2017 to Feb 2018)
- Broken tool observed in pellet press during production — not documented in batch record, no deviation initiated
- Pharmacists conducting QC review stated they "did not know what they were reviewing"
- Head of QA stated they only sign to check paperwork is filled out, not to verify data accuracy
- Gowning sampling revealed Coagulase-negative Staphylococcus and Micrococcus spp. with 8-month delay in initiating deviation
Wells Pharmacy Network LLC
- Continued compliance issues identified across multiple inspections spanning nearly a decade
- FDA issued untitled letter citing persistent manufacturing and quality system deficiencies
Pre-Inspection Preparation
How to Prepare
- 1 Audit deviation initiation timelines — Page has documented 8–9 month delays between events and deviation initiation. Ensure deviations are initiated within 24–48 hours of discovery.
- 2 Conduct mock interviews with QA/QC reviewers — Page directly interviews pharmacists and QA personnel and asks them to explain their review process. Train all reviewers to articulate what they check and why.
- 3 Verify environmental monitoring is conducted during dynamic (production) conditions — static or recertification-only monitoring will be cited.
- 4 Document all production anomalies in real time — Page checks batch records against physical observations on the floor. Any broken equipment or deviations must be documented immediately.
- 5 Implement daily ISO 5 environmental monitoring each day sterile products are manufactured — Page has cited facilities that only monitor periodically.
- 6 Investigate every environmental monitoring excursion to organism identification level — Page cites facilities that find TNTC plates without investigation.
- 7 Ensure equipment cleaning validation between batches on non-dedicated equipment — document cleaning procedures and verification.
- 8 Review all fingertip and gowning qualification records — ensure all personnel entering classified areas have current qualifications.
- 9 Validate sterilisation processes and maintain current documentation — Page cites absence of sterilisation validation at compounding facilities.
- 10 Ensure air pressure differential monitoring is continuous with alarmed systems, or establish a documented periodic monitoring schedule.
- 11 Prepare for extended inspections — Page's inspections range from 8 days to 6 weeks, so ensure team stamina and documentation access.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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