FDA inspections are inevitable for drug manufacturers — whether to secure pre-approval for a new product, ensure GMP compliance, follow up on post-market reports, or investigate complaints and recalls. While the reason may differ, FDA investigators follow established procedures, and knowing what to expect can make the difference between a smooth inspection and a disruptive one.
In this webinar, Larry Stringer, Former FDA Supervisor and Investigator with more than 30 years at the U.S. Food & Drug Administration, will share first-hand insights from conducting hundreds of inspections and leading revisions to FDA’s Investigations Operations Manual (IOM) — the primary reference for field investigators.
You’ll gain a clear understanding of how investigators approach inspections, what they are evaluating, and — most importantly — how your team can prepare and respond to protect your operations.
Key Questions Answered
- What does the investigator do before arriving on site?
- Why is FDA inspecting my facility?
- What are the limits of an inspection?
- What happens during the inspection?
- What does the investigator do afterward?
- What should you do once the inspection is complete?
- How can you prepare in advance to minimize risk?
Why Attend?
Benefit from the perspective of a seasoned FDA professional who helped shape inspection policies. Walk away with actionable strategies to strengthen your compliance posture and ensure your next FDA inspection runs smoothly.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
