SBS - The Best Value in QMS software

New Facility register with FDA

#1
We are a pharmaceutical company of Dietary Supplement and we are currently register with the FDA but we in a process of obtaining a new building at a different location.

Does the new building at a different location needs to be register separately with the FDA or Do we need to add it to our current registration ?

By the way, we are keeping both locations.
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Refer my earlier post here: FDA Registration Requirements for Multiple Sites (elsmar.com)

In another document from FDA, it is stated, "Under the final rule’s definition of ‘‘establishment,’’ two establishments located 5 miles apart would not qualify as being at ‘‘one general physical location’’ and would therefore require two separate registrations. Each establishment would be associated with its own UFI and establishment registration number". See comment 46 on page 20 of 55 (around mid page in the middle column: 2016-20471.pdf (govinfo.gov)

So from your question, I do not know how far is the second location from the first one.
 
#3
Thanks for your help.

Our second location will be about 1/2 mile from the main building.

The new location will be our Main building (Headquarters). our old (current) location will be used for storage.

Do I have to get a new registration for the new Building ?
 

William55401

Quite Involved in Discussions
#5
Good info above. Here's a rule of thumb I heard from an ex-FDA person. Is it a campus? Can you walk it? If you need to drive, it is not a campus and separate registration is indicated. HTH
 
Thread starter Similar threads Forum Replies Date
M Register, list and pay the Device Facility User Fee with FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
P New Facility - 6 to 12 Months Before We're Allowed to Register? IATF 16949 - Automotive Quality Systems Standard 9
C Revalidation of Process Equipment for Equipment Transfered to New Facility. ISO 13485:2016 - Medical Device Quality Management Systems 5
B Procedure facility license in karnataka Manufacturing and Related Processes 3
V Clause 7.1.3.1 Plant, facility, and equipment planning Lean in Manufacturing and Service Industries 0
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N Looking for Gamma sterilization facility in China ISO 13485:2016 - Medical Device Quality Management Systems 4
S Starting an ISO 41001:2018 Facility management system Other ISO and International Standards and European Regulations 3
M How do you Audit an Distribution Facility according to MAQMSR IATF 16949 - Automotive Quality Systems Standard 3
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
Y Performing product audits in a manufacturing facility Manufacturing and Related Processes 13
M Informational FDA Preps for Device Shortages as Another Sterilization Facility Will Close Medical Device and FDA Regulations and Standards News 0
B ISO 13485 Transferring a product from manufacturing facility 1 to manufacturing facility 2 ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Aviation MRO Project facility coming to U-Tapao airport in Thailand - Help Career and Occupation Discussions 2
Edward Reesor Design owner: The line between inventor and manufacturing facility Manufacturing and Related Processes 3
J Facility Expansion and ISO 14001 ISO 14001:2015 Specific Discussions 1
A Machine Relocation within Facility - Is re-validation required? ISO 13485:2016 - Medical Device Quality Management Systems 8
C Documenting Cleaning Production Lines in Medical Device Pkg facility ISO 13485:2016 - Medical Device Quality Management Systems 1
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
C Documenting Cleaning Production Lines in Medical Device Pkg facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
shrutisancheti Upgrading medical device at healthcare establishments (user facility) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Sidney Vianna ISO 41001:2018 - System Standard for Facility Management Other ISO and International Standards and European Regulations 8
A Medical Device manufacturing Facility Test audit IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
optomist1 Military Test Facility Certification Requirements Reliability Analysis - Predictions, Testing and Standards 5
Jane's Should the facility landlord be an approved supplier? Supplier Quality Assurance and other Supplier Issues 12
P Secondary packaging operations in medical device facility Manufacturing and Related Processes 1
K Change of Sterilization Vendors / Facility US Food and Drug Administration (FDA) 1
S Plant within a Plant - Does anyone currently manage their facility this way? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B ISO 9001:2015 8.4 External Providers - If work is transferred to a separate facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M IATF 16949 - 7.1.3.1 Plant, Facility, and Equipment Planning - Interpretation IATF 16949 - Automotive Quality Systems Standard 8
6 Craft Beer StartUp Facility Design Food Safety - ISO 22000, HACCP (21 CFR 120) 2
I NADCAP In Manufacturing Facility with Small Laboratory - Measurement & Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F Setting up a new sterilization unit in a new facility 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
V Site Master File for multiple business units within same premises/facility Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
S Does a Research facility require DEA registration ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Quality Plan to decommission a Medical Device Facility Decommissioning and Transfer Quality Manager and Management Related Issues 1
T Subletting space in a facility and certifications Quality Manager and Management Related Issues 1
C Service and maintenance in an initial importer facility USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J MR Testing Facility recommendations in US, Germany, or Asia US Food and Drug Administration (FDA) 3
J Looking for Testing facility to do testing of x ray sensors for us US Food and Drug Administration (FDA) 1
Q Can a non AS9100 facility build a Aerospace product? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M TS16949 Design Exclusion when Design is done in a different Facility ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H FDA/PMA/Medical Device/Before submission/Manufacturing facility change US Food and Drug Administration (FDA) 1
S FDA facility Registration Imported Legacy Blogs 2
M Building Production / Manufacturing Facility for Class 2 Medical Device US Food and Drug Administration (FDA) 1
S Temporary Facility Used For Production - Use of existing Third Party Logos ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Marc Pipe Break At Coal Facility Contaminates West Virginia Waterway Miscellaneous Environmental Standards and EMS Related Discussions 0
T Is Testing in a Third Party Facility Subcontracting? General Measurement Device and Calibration Topics 2

Similar threads

Top Bottom