Class II/III and Component Manufacturer Moving to New Location

SpiderMonkey

Registered
Our company is a contract manufacture for Class II/III finished devices and components. We have multiple sites in the US and Europe. We are starting the process of evaluating consolidating some of our US based sites.

My question primarily is in regards to FDA requirements for moving a registered facility.
  • What type of notification needs to be made to the agency and when?
  • Does the agency require an inspection of the new consolidated site?
  • What does the timing for approval typically look like?
As a contract manufacturer we will have to work closely with our customers and our notified body on qualification, audits, timing, etc.... as it is likely that our customers will need to make FDA submission as well for the relocation of manufacturing of their finished devices.

If anyone has gone through a similar process, what have your experiences been and how long did it take to get full regulatory and customer approvals for such a move?
 

Aj grant

Registered
the following FDA requirements generally apply:

1. Notification to the FDA:
• You must update your establishment registration information with the FDA within 30 days of any changes, including moving to a new location. This is done through the FDA’s Unified Registration and Listing System (FURLS)/Device Registration and Listing Module (DRLM).
• Additionally, you may need to update your device listings to reflect the new manufacturing location.
2. FDA Inspection:
• The FDA does not always require a pre-approval inspection of the new site before you start operations. However, it reserves the right to inspect the new facility at any time to ensure compliance with the Quality System Regulation (QSR) and other applicable regulations.
• It’s also possible that if the move significantly changes the manufacturing process or environment, an inspection may be more likely.
3. Timing for Approval:
• There is no formal “approval” process for moving a facility per se, as the focus is on ensuring continuous compliance with FDA regulations. Once you update your registration and listings (if necessary), you can begin operations at the new location unless specifically instructed otherwise by the FDA.
• However, the timing for an FDA inspection, if it occurs, can be unpredictable and may vary based on the agency’s priorities and resources.

Check out- fda device-registration-and-listing guidance document and
fda-guidance-documents/manufacturing-site-change-supplements-content-and-submission
 

Aj grant

Registered
Of course you have to notify your customers prior to the move as you indicated. This response also assumes you will perform all other compliance tasks (eg IQ/OQ/PQs)) as required.
 
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