FDA Quality Audits 21cfr820.22 - Audits by the head of the company not allowed

A

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#1
#1
Small companies don't have a chance! :frust:

According to FDAnews.com:

AUDITS CANNOT BE CONDUCTED BY THE HEAD OF THE COMPANY

The president of a company cannot conduct internal quality audits, the FDA told the Ludwig Medical President Gerald Ludwig in a recent warning letter.

Following a May inspection, the company, which manufactures sterile specimen traps, was issued a 483 for failure to conduct quality audits, among other things. According to the FDA, the company had not conducted a quality audit since 1991.

In a response letter to the agency, Ludwig proposed he be allowed to conduct a self-audit. The FDA rejected the proposal in an Aug. 13 warning letter, saying the proposal is not adequate because the Quality System Regulation (QSR) expressly prohibits such audits.

To see a copy of the Aug. 13 letter, go to http://www.fda.gov/foi/warning_letters/g4232d.pdf

How does the regulation prohibit this? It states:
Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.

More FDA/Government BS. :mad:
 
Elsmar Forum Sponsor
D

db

#2
#2
Re: Fda Quality Audits 21cfr820.22

Al Rosen said:
Small companies don't have a chance! .... Etc.
Click to expand...
I have seen this before also in ISO and QS. In all cases, the determination was that the President has direct responsibility and therefore, cannot audit. Also, in all cases, it was determined that others in the organization could audit, only the President was excluded.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Are Internal Audits of the Quality System required by the FDA yearly? Internal Auditing 6
M Loss of a Quality Record - FDA Inspection Records and Data - Quality, Legal and Other Evidence 4
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
M Medical Device News FDA News - 06-09-18 - FDA - Quality in 510(k) "Quik" Review Program Pilot Other US Medical Device Regulations 0
M FDA Considers Shift on Medical Device Quality System Regulations - 2018 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V Data Quality and Data Integrity - Audit Trail - Part 11 - WHO - FDA - MHRA - PDA US Food and Drug Administration (FDA) 6
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
J FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M FDA's Medical Device Quality Systems Manual Withdrawn (2013) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
A What documents would an FDA auditor want to see in an FDA Audit of Quality System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
R Is a Quality Manual a requirement for FDA registration? US Food and Drug Administration (FDA) 5
AnaMariaVR2 FDA Commissioner: Margaret Hamburg challenges drugmakers 2 supercharge Quality US Food and Drug Administration (FDA) 0
A How many processes for an FDA Quality System (QSR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
AnaMariaVR2 FDA embraces ICH Guidance on Pharmaceutical Quality Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
O Are the ISO and CE requirements same as FDA for a Quality Management System? Other Medical Device and Orthopedic Related Topics 5
E FDA Quality Systems and DAMAS (Dental Appliance Manufacturers Audit Scheme) US Food and Drug Administration (FDA) 3
AnaMariaVR2 FDA: Novartis "Ineffective Quality System" US Food and Drug Administration (FDA) 3
G FDA's CDRH report "Barriers on Medical Device Quality" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Y FDA News bulletin: It's the FDA's fault! FDA at Fault for Poor Quality Devices US Food and Drug Administration (FDA) 6
V The Difference between Specifications and Quality Attributes - FDA Definitions US Food and Drug Administration (FDA) 7
S FDA 21 CFR 820 QSR Quality Manual example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F PhD in Quality/Quality Management/FDA? Professional Certifications and Degrees 4
M FDA quantification of AQLs or Quality Levels AQL - Acceptable Quality Level 4
GStough FDA QSR (Quality System Regulation) Training Needed in the Southeastern USA Training - Internal, External, Online and Distance Learning 7
D FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
R FDA Part 820 Quality System Regulation - 820.198 Complaint files ISO 13485:2016 - Medical Device Quality Management Systems 20
I Developing a ISO/FDA Compliant Supplier Quality Assurance System - Medical Device Supplier Quality Assurance and other Supplier Issues 10
Ajit Basrur FDA Requirements for Document Approval by Quality Department US Food and Drug Administration (FDA) 6
R Rubber Initial & Inspection Stamps - Valid or a violation of FDA quality guidelines? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
H Implementation of the FDA requirements into the existing Quality Management System US Food and Drug Administration (FDA) 7
Q FDA Quality Plan - What kind of quality plan is required for FDA QSR? ISO 13485:2016 - Medical Device Quality Management Systems 2
Sidney Vianna How costly can a quality system problem be? Guidant vs. the FDA US Food and Drug Administration (FDA) 1
S Quality System Database Validation - FDA's General Principles of Software Validation Qualification and Validation (including 21 CFR Part 11) 20
W Breaking into quality management in an FDA environment Career and Occupation Discussions 2
R Quality Manual - Are there new requirements since FDA issued SMG 2020 Quality Management System (QMS) Manuals 3
S Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
B FDA Quality Plan - Document Management Responsibility, section 820.20 d 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
L Seeking: cGMP FDA-based Quality Manual with ISO 9001 and EN Requirements Quality Management System (QMS) Manuals 4
Q Looking for Best ISO 13485/FDA QSR Quality System Development Software Quality Assurance and Compliance Software Tools and Solutions 4
H Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6

Similar threads

Top Bottom