Has the facility been inspected? question in Certificate to Foreign Government application

#1
During the application for a Certificate to Foreign Government with CDRH, there is a step that ask for "Has the facility been inspected by FDA?" and provide date of last inspection. I know this is when the reviewer will go to look if the applicant has any outstanding observations from the last inspection and may be ground for denial of the CFG application. Does this means for new applicant that had not had any FDA inspection in the past, the CFG will be rejected as well? Is Inspection mandatory? ISO 13485 certification won't suffice as there is no place that asks for this cert?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
R After the corporate facility has been TS16949 audited does a 90 day time clock start? IATF 16949 - Automotive Quality Systems Standard 3
T Has anyone done both Quality and Facility Security Officer (FSO) roles ? Career and Occupation Discussions 8
S Has anyone had experience with Intellect eQMS? ISO 13485:2016 - Medical Device Quality Management Systems 0
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
D IATF Requirements if remote plant has no interface with OEMs who are part of IATF? IATF 16949 - Automotive Quality Systems Standard 6
O PPAP'ed part manufacturer has discontinued production Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 7
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
K 10 parts, 4 operators, 3 replications and each part has 3 location to measure. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
L GRR for a tolerance that has changed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Nicole Desouza Who has to be compliant with REACH Declarations? REACH and RoHS Conversations 11
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Al Rosen Would an MRP system that has been in use for over 10 years require validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
I Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3

Similar threads

Top Bottom