SBS - The best value in QMS software

FDA Registration food facility - We operate under CGMP guidelines

SMBIZZQA

Starting to get Involved
#1
I'd like some feedback please: We are FDA registered as a Contract MFG, our facility manufactures class 1 medical products and subassemblies for various companies. Have a customer that now requires us to become registered as a 'food facility" due to their materials fall under the category of food. These ingredients are blended and converted in a medical product. We have manufactured this for over 5 years for this customer and they have now found out that the classification needs to be changed.
We operate under CGMP guidelines, are ISO13485 certified, manufacture 1 product that requires a microbiologist audit every other year and operate under "controlled' environment guidelines.
Other than going through the registration process and potential inspection from FDA, is there anything that we need to put in place prior to registration?
Thank you
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C FDA Registration Requirements for Multiple Sites 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
D FDA Registration - MD, OTC or Dietary Supplement US Food and Drug Administration (FDA) 0
Ajit Basrur FDA - Tobacco Registration and Product Listing US Food and Drug Administration (FDA) 2
P FDA's DRLM (Device Registration & Listing Module) Listing Number Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
I FDA Medical Device Registration - Scenario - Two Companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Z Re-packager/Re-Labeler - FDA Registration question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
J FDA classification and registration for a software plugin 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Is FDA Establishment Registration required for clinical manufacturing ? US Food and Drug Administration (FDA) 3
S FDA Establishment Registration for Testing Laboratories 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B How does a Kit Assembler proceed after FDA Establishment Registration? Other US Medical Device Regulations 3
A FDA Registration for Mulitple Site Locations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S FDA facility Registration Imported Legacy Blogs 2
E FDA guidance on Foreign establishment registration US Food and Drug Administration (FDA) 3
J Establishment registration FDA 'Foreign exporter' 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B How to change the FDA Device Registration and Listing Module - Owner/Operator Other US Medical Device Regulations 10
Y Thai FDA Medical Device Registration with 2 distributors Other Medical Device Regulations World-Wide 2
D Compliance to 21 CFR Part 11 Require Registration to FDA? Qualification and Validation (including 21 CFR Part 11) 9
thisby_ FDA, IEC 60601-1 and IEC 60601-1-2 - Registration of similar product US Food and Drug Administration (FDA) 3
R Is a Quality Manual a requirement for FDA registration? US Food and Drug Administration (FDA) 5
B Need help in adding second location to FDA Registration Other US Medical Device Regulations 4
E Initial Registration of an Establishment with FDA US Food and Drug Administration (FDA) 5
ScottK Some hypothetical situations regarding FDA registration: 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Training on FDA "Establishment Registration" US Food and Drug Administration (FDA) 2
Q FDA Registration and Importing Medical Device Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B FDA - New Establishment Registration and Device Listing Requirements Other US Medical Device Regulations 14
R Do we need FDA Establishment Registration for Bone Screws? US Food and Drug Administration (FDA) 21
M Contract Manufacturer of a Non-Invasive, Non-Sterile Device and FDA Registration US Food and Drug Administration (FDA) 2
A Convenience Kits - FDA Registration Responsibilities and Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D FDA Establishment Registration for Software Company US Food and Drug Administration (FDA) 8
C FDA Registration as a Marketing Tool - Contract Manufacturer of Components US Food and Drug Administration (FDA) 8
K FDA Medical Device Registration and Listing Number and Information Other US Medical Device Regulations 4
L Distributor Registration - FDA Registration Requirements for a Distributor 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
bio_subbu US FDA Guidance on Medical Device Establishment Registration and Listing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Questions about FDA registration and 510k application 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Q FDA: File an electronic Registration of Drug Establishment/Labeler Code 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A FDA - Registration & Listing Updating + when Purchasing another Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
F Accelerate the possesing of ISO 13845 and CAN/CSA-certifications a FDA registration 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S FDA Registration - How to renew our registration for medical devices to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Ajit Basrur Change in FDA Establishment Registration Fee process wef Oct 1, 2008 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
H Exempt from FDA Registration or not? Company that makes parts for medical devices ISO 13485:2016 - Medical Device Quality Management Systems 11
S FDA Annual Registration - Any harm to be FDA (form FDA 2891a) registrated 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B New FDA Forms - 2891 Registration of Device Establishment, FDA 2892 Device Listing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6

Similar threads

Top Bottom