Compliance & Inspections

A documented plan listing corrective actions, preventive actions, owners, due dates, and effectiveness checks to address identified issues.

An inspection triggered by a specific concern, such as suspected fraud, serious adverse events, data integrity issues, or recall. Can be unannounced.

A document issued by FDA investigators at the conclusion of an inspection listing observations of potential regulatory violations.

An inspection focused on clinical trial conduct and data integrity at sponsor/CRO/sites to verify GCP compliance and reliability of trial data.

An inspection of manufacturing/testing facilities to assess compliance with GMP and confirm suitability for producing regulated products.

Ongoing state of compliance and documentation such that the organisation can host a regulatory inspection at any time with complete, accurate, and retrievable records.

A simulated inspection conducted internally or by consultants to assess readiness, identify gaps, and train staff for regulatory inspections.

An inspection assessing compliance with pharmacovigilance obligations and systems (e.g., PSMF, processes, contracts, reporting).

Inspection of manufacturing and/or clinical sites conducted by the regulatory authority before approving an application (e.g. NDA, BLA, MAA) to verify data and compliance.

A written response describing corrective actions, timelines, and evidence addressing FDA inspection observations.

An FDA enforcement communication describing significant violations and requesting corrective actions, often following inspections or review of promotional materials.