Regulatory requirement for Receiving Inspection reporting to Quality Org.?

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
...that your receiving inspection operation is being influenced to push items through because production needs them. At least if RI is under QA/QC you can avoid that perception of bias.
Actually, the FDA acknowledges the fact that production might get a hold AND use incoming products that have not been fully verified at receiving inspection:

FDA has permitted manufacturers to use incoming items that had not yet been proven acceptable for use, provided that the manufacturer maintained control of the unapproved items and could retrieve the product that contained the unapproved items before distribution. Therefore, the requirement that product ‘‘shall not be used or processed until * * * verified’’ has been deleted from § 820.80(b), now entitled ‘‘Receiving acceptance activities.’’ However, FDA emphasizes that while the product can be used in production prior to verification, it cannot be distributed prior to verification. FDA does not permit the distribution of unapproved product through an urgent use provision, because all finished devices must comply with § 820.80(d), ‘‘Final acceptance activities,’’ before they are released for distribution.​
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
T Regulatory Standards & Certification Requirement - Headband to monitor mental health Other Medical Device Regulations World-Wide 4
chris1price Is there a regulatory (MDD, MDR, FDA, ISO, etc) requirement to perform a mock recall? CE Marking (Conformité Européene) / CB Scheme 4
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Is there a regulatory requirement for clinician review for pFMEAs? ISO 14971 - Medical Device Risk Management 2
R Medical Device Smartphone App Regulatory Requirement and Labeling US Food and Drug Administration (FDA) 1
V FDA regulatory requirement on the lot number convention for medical devices US Food and Drug Administration (FDA) 2
E Is there a specific regulatory requirement for 100% inspection of IFUs? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J What to be reported on "New or Revised Regulatory Requirement" at Management Review? Management Review Meetings and related Processes 8
G US Risk Assessment OH&S Regulatory Requirement(s) Occupational Health & Safety Management Standards 5
C Regulatory Requirement Updates? Medical Device Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 6
C What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers Records and Data - Quality, Legal and Other Evidence 9
N Statutory and regulatory requirement examples in metal fabrication Various Other Specifications, Standards, and related Requirements 8
A Keeping prototype devices - Is there a regulatory or compendial requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
L Are Fireproof Cabinets a Regulatory Requirement for record storage? FDA or EU Records and Data - Quality, Legal and Other Evidence 23
R Ethics: Ethical Question - Knowingly Violating a Regulatory Requirement Philosophy, Gurus, Innovation and Evolution 20
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Worldwide Regulatory Knowledge Other Medical Device Regulations World-Wide 3
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 17
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 10
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
Watchcat Year of the Regulatory Watchcat Other US Medical Device Regulations 6
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 43
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
S Regulatory Medical Device PMA Plans US Food and Drug Administration (FDA) 2
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2

Similar threads

Top Bottom