“The best way to survive an FDA inspection is to be prepared for it!”

An FDA Pharmacovigilance inspection is generally unannounced. However, if it pertains to a foreign/ Non-US site, it is likely to be a pre-announced one.

What are the types of FDA Pharmacovigilance inspections?

1. Post Marketing Adverse Drug Experience (PADE)

2. Risk Evaluation and Mitigation Strategies (REMS)

3. Post Marketing Studies and Clinical Trials (PMRs)

If a pharma company does not have REMS for any of its products and there are no clinical studies being conducted for its products, then one can safely assume that it is going to be a PADE inspection.

Risk-based Site Selection

1. Inspection History – Never inspected, inspection findings from other program areas (e.g. GMP inspection), triggered from previous PADE inspection response

2. Product Portfolio – New products, recalls/ patient exposure, Issues in submission (ICSR/PADER)

3. Firm Information – Corporate changes, internal FDA information, complaints, info from other authorities

PADE Inspection Coverage

Quality Management System:

• Written procedures
• Root cause analyses and corrective actions for deviations
• Training documents

ICSRs

• ADEs from all sources
• Confirmation of electronic submissions
• Late, missing, incomplete, or inaccurate 15-day reports
• Follow-up processes

Periodic Reports

• Late or missing periodic reports
• Late or missing annual reports
• Waivers

Others

• Product list (approval date, status, etc.)
• The organization, roles and responsibilities

Agreements

• Safety Contracts – with Vendors
• Safety Data Exchange Agreements

Inspection Categorization/Grading/Classification

Unlike other inspections where the findings are categorized into Critical, Major and Minor (others), FDA categorizes inspections into

1. No Action Indicated

Objectionable conditions or practices were not found

2. Voluntary Action Indicated

Objectionable conditions or practices were found but do not rise to the level of regulatory action

3. Official Action Indicated

Regulatory and/or administrative actions recommended, such as untitled letter, warning letter, regulatory meeting

A Complete and Timely Written Response is generally required to be submitted within 15 calendar days. The response letter needs to be well reasoned, taking into consideration all the corrective and preventive actions.

FDA Guidances:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment

https://www.fda.gov/media/84969/download

Inspection Classification Database Search:

https://www.accessdata.fda.gov/scripts/inspsearch/