FDA Experience to help your FDA compliance

By Brandon Boone

As lead consultant and owner of Expert FDA Help, I draw on more than 15 years of front‑line FDA import and investigation experience to deliver practical, enforcement‑tested compliance solutions for importers, brokers, and manufacturers of FDA‑regulated products.

Deep inspectional and enforcement background

- Conducted 150 FSVP inspections across standard, very‑small importer, dietary supplement, produce (Produce Safety Rule), high‑risk and Center‑directed categories, including inspections tied to product recalls.

- Performed VQIP inspections to verify rigorous food‑safety controls and accurate data transmission.

- Hands‑on experience with electronic entry review, physical examinations across all FDA commodities, and sampling with strict chain‑of‑custody and protocol adherence.

Operational leadership and training

- Managed entry review pilot operations—supervising staff, ensuring timely admissibility decisions, and coordinating appropriate field work to maintain operational continuity.

- Member of the Division of West Coast Imports (DWCI) Training Cadre and FSVP Cadre, training FDA personnel in FSVP, entry review, field exams/sampling, investigations, CBP referrals, and LAX import operations.

- Authored the LAX‑Resident Post SOP to accelerate onboarding and operational readiness for new hires and transfers.

Tools, systems, and process development

- Led development and cadre training for a Potential Hazards application that streamlines hazard identification during FSVP inspections.

- Participated as an Subject Matter Expert (SME) on the Import Certification Exam workshop, ensuring exam content reflects operational realities across FDA import functions.

Cross‑agency coordination and investigations

- Served as FDA representative at the LAX CBP Centralized Examination Site, collaborating with CBP on exam priorities, stakeholder engagement, and training.

- Participated in multi‑agency task forces with CBP, NOAA, CDC, OCI, HSI, FBI, DEA, state public health partners, and others to resolve complex enforcement and public‑health issues.

- Investigations include fraudulent COVID‑19 items (counterfeit vaccines, test kits, respirators), infant formula, and product recalls such as Enoki mushrooms.

- Consistently strong performance appraisals (2013–2016 perfect scores as Investigator; Import Specialist appraisals: 2022 — 4.67/5; 2023 — 4.60/5; 2024 — 4.80/5).

What this means for clients of Expert FDA Help

• Practical, enforcement‑tested guidance: I translate FDA inspection practices and expectations into proactive, audit‑ready systems for suppliers, importers and brokers.

• Faster remediation and defensible decisions: my experience making admissibility determinations and coordinating with CBP and other agencies helps clients respond quickly and effectively to holds, examinations and recalls.

• Training and SOP development: I design operations, SOPs, and training that mirror FDA priorities to reduce inspection risk and improve regulatory performance.

• Cross‑agency navigation: proven ability to coordinate with CBP, CDC, state partners and enforcement agencies to resolve complex issues and protect product movement with compliant controls.