USFDA Inspections: What You Need to Know as a New Business Owner


The U.S. Food and Drug Administration (FDA) conducts various types of inspections to ensure compliance with regulations governing food, drugs, medical devices, cosmetics, and other products. The timelines and overall processes for these inspections can vary depending on factors such as the type of inspection, the nature of the product being regulated, and the specific circumstances surrounding the inspection. Here’s a general overview:

Types of Inspections:

Pre-Approval Inspection (PAI):
  • Purpose: Conducted before the approval of a new drug, medical device, or biological product to ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant regulations.
  • Timeline: Typically occurs after a regulatory submission and can occur several months before approval.
Good Manufacturing Practices (GMP) Inspection:
  • Purpose: Focuses on ensuring that manufacturing facilities comply with regulations governing the quality control and production processes for drugs, medical devices, dietary supplements, and other products.
  • Timeline: Can occur periodically based on risk assessment or triggered by specific events.
Bioresearch Monitoring (BIMO) Inspection:
  • Purpose: Ensures compliance with regulations governing the conduct of clinical trials.
  • Timeline: Occurs during or after clinical trials and can vary depending on the stage of the trial.
Post-Market Surveillance Inspection:
  • Purpose: Conducted after a product has been approved or cleared for marketing to ensure ongoing compliance with regulations and monitor adverse events or product defects.
  • Timeline: Can occur periodically or in response to specific issues such as complaints or adverse event reports.
For-Cause Inspection:
  • Purpose: Triggered by specific events such as consumer complaints, adverse event reports, or product recalls to investigate potential violations of regulations or quality issues.
  • Timeline: Can occur relatively quickly after the triggering event.
Compliance Follow-Up Inspection:
  • Purpose: Ensures that corrective actions have been implemented following a previous inspection where deficiencies were identified.
  • Timeline: Occurs after a specified period to verify compliance.
Risk-Based Inspection:
  • Purpose: Prioritizes inspections based on factors such as the potential risk to public health, compliance history of the facility, and the type of product being manufactured.
  • Timeline: Can occur periodically based on risk assessment.
Surveillance Inspection:
  • Purpose: Routine inspections conducted periodically to monitor compliance with FDA regulations and ensure ongoing safety and quality of products.
  • Timeline: Typically scheduled at regular intervals based on risk assessment.

Overall Process:

Notification: The FDA typically notifies the facility in advance of an upcoming inspection, although some inspections may be unannounced.

Preparation: The facility prepares for the inspection by organizing relevant documentation, ensuring the facility is in compliance with regulations, and training staff on inspection procedures.

On-Site Inspection:

  • FDA inspectors visit the facility to conduct the inspection.
  • Inspectors may review documentation, observe manufacturing processes, and interview staff members.

Findings: At the conclusion of the inspection, the FDA may issue a Form FDA 483, which outlines any observations of non-compliance with regulations.

Response: The facility has an opportunity to respond to the FDA’s observations and implement corrective actions to address any deficiencies.

Follow-Up: For inspections resulting in significant findings, the FDA may conduct follow-up inspections to verify that corrective actions have been implemented and compliance has been achieved.

It’s important to note that the timelines and specific procedures can vary depending on the circumstances of each inspection and the regulations applicable to the product and facility.

Contact Us:

We at https://www.gxpcellators.comGxP Cellators are dedicated to providing comprehensive support to our life-sciences partners during their regulatory site inspection programs. Our team is committed to ensuring that our clients are fully prepared for inspections and able to demonstrate compliance with all relevant regulations. To achieve this, we offer various essential services, including conducting GAP Assessments, performing remote/on-site Mock Audits, responding to regulatory bodies during inspection, and providing back and front office support. Additionally, we offer Site Audit Readiness Programs to help our partners maintain a state of constant preparedness. If you require any assistance during your regulatory success journey, please feel free to reach out to us at

by admin

I am a seasoned GxP expert and the founder and CEO of GxP Cellators, a consulting firm that provides GxP advisory and auditing services to clients across the globe. My mission is to help clients achieve excellence in quality, compliance, and remediation, and to foster a robust quality culture in their organizations.

Leave a Reply

Your email address will not be published. Required fields are marked *

Our Presence

Saskatchewan, CanadaFrankfurt, Germany

Toronto, CanadaNorth Carolina, USA

Indiana, USACalgary, Canada