Interesting Discussion Requirements for selling a Food product in USA

DannyK

Trusted Information Resource
#1
A company in Canada wishes to sell a GRAS product in USA.

Are there regulatory requirements for interstate marketing a GRAS food product? Or is FDA registration of product and establishment enough?”

Note that the supplier is GMP.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
D What are the requirements for selling Alcohol Swabs in USA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
C Labeling requirements when selling demo Medical Device equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
I Requirements for selling Class I Medical Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 4
B Regulatory Requirements are for selling Medical Devices in the Ukraine? Other Medical Device Regulations World-Wide 9
Q Labeling requirements when selling products manufactured in China Various Other Specifications, Standards, and related Requirements 4
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
G MDR translation requirements EU Medical Device Regulations 3
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
D IATF16949 - Interpretation of Customer Requirements clauses Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
M IEC 61000-4-2: Requirements for coating declared as insulating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3

Similar threads

Top Bottom