The Elsmar Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Failure Modes Services and Solutions to ProblemsElsmar Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Discussion Forums > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
Forum Username

Wooden Line

FDA Audit Documentation - Recently released FDA Warning Letter


Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links


Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
21 cfr part 211 - finished pharmaceuticals cgmp, 21 cfr part 820 - med. device mfger. qsr requirements, fda (food and drug administration), fda requirements, required documents, required procedures, required processes, required records
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 14th December 2011, 11:01 AM
alex.Kennedy

 
 
Total Posts: 53
Caution FDA Audit Documentation - Recently released FDA Warning Letter

A recently released FDA Warning Letter portrays a tighter interpretation of 21 CFR part 820.50, in so much as they expect to be able to review documented record for items a) to d) below. It must also be understood that other branches of the FDA (Drugs & Bio) have ascertained that when 21 CFR 211 lacks detail; they will audit to detail in 21 CFR 820 (if any).

Although the wording used in a) & b) would definitely identify them as applicable to medical devices parts; c) & d) are not. Also the fact that they mention in b) & c); that these requirements are applicable to - contractors and services rendered. This for many companies will be very disconcerting.

Extract from warning letter:

a) Your firm has not documented the evaluation and approval of suppliers of components used in the manufacture or assembly of the xxxxx xxx xxxx measurement device.

b) Your firm does not have a documented agreement with any component suppliers or contractors to notify it of changes made in the components supplied or services rendered.

c) Your firm has not established the requirements that must be met by suppliers and contractors.

d) Your firm does not maintain an approved suppliers list.
Precise extraction from WL CMS Case #175552

Alex Kennedy
Thank You to alex.Kennedy for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 14th December 2011, 11:42 AM
MIREGMGR

 
 
Total Posts: 3,662
Re: FDA Audit Documentation

Our understanding since 1996, at least in regard to matters that might be subject to FDA inspection, has been "if it's not documented, it didn't happen".
Thanks to MIREGMGR for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 14th December 2011, 12:33 PM
sagai

 
 
Total Posts: 1,094
Re: FDA Audit Documentation - Recently released FDA Warning Letter

Thank you Alex for sharing, it is really a good way to collect impressions and thoughts!
Regards, Szabolcs
  Post Number #4  
Old 14th December 2011, 12:35 PM
sagai

 
 
Total Posts: 1,094
Re: FDA Audit Documentation

what is the minimal criteria for "documented"?
  Post Number #5  
Old 14th December 2011, 02:47 PM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,012
Re: FDA Audit Documentation

Quote:
In Reply to Parent Post by MIREGMGR View Post

Our understanding since 1996, at least in regard to matters that might be subject to FDA inspection, has been "if it's not documented, it didn't happen".
Quote:
In Reply to Parent Post by sagai View Post

what is the minimal criteria for "documented"?
In my mind [and practice], "documentation" means you have
  1. a written plan for an activity
  2. a record (hard copy or electronic) of the activity being performed
  3. periodic evaluation (recorded) of the activity record to compare against the plan (audit and management review?)
  4. record of the action or non action taken after the evaluation (this presupposes management makes due and timely communication to concerned parties, including regulators)
  Post Number #6  
Old 14th December 2011, 10:59 PM
Ronen E

 
 
Total Posts: 2,490
Re: FDA Audit Documentation - Recently released FDA Warning Letter

Quote:
In Reply to Parent Post by alex.Kennedy View Post

A recently released FDA Warning Letter portrays a tighter interpretation of 21 CFR part 820.50, in so much as they expect to be able to review documented record for items a) to d) below. It must also be understood that other branches of the FDA (Drugs & Bio) have ascertained that when 21 CFR 211 lacks detail; they will audit to detail in 21 CFR 820 (if any).

Although the wording used in a) & b) would definitely identify them as applicable to medical devices parts; c) & d) are not. Also the fact that they mention in b) & c); that these requirements are applicable to - contractors and services rendered. This for many companies will be very disconcerting.

Extract from warning letter:

a) Your firm has not documented the evaluation and approval of suppliers of components used in the manufacture or assembly of the xxxxx xxx xxxx measurement device.

b) Your firm does not have a documented agreement with any component suppliers or contractors to notify it of changes made in the components supplied or services rendered.

c) Your firm has not established the requirements that must be met by suppliers and contractors.

d) Your firm does not maintain an approved suppliers list.
Precise extraction from WL CMS Case #175552

Alex Kennedy
validation online
Thanks for highlighting the subject; however, I think this is old news to any manufacturer following the FDA's QSR manual and/or ISO 13485.

Cheers,
Ronen.
  Post Number #7  
Old 16th December 2011, 08:50 AM
alex.Kennedy

 
 
Total Posts: 53
Re: FDA Audit Documentation - Recently released FDA Warning Letter

I appreciate the comments made by forum readers and I do agree that the universal understanding with regulators was if it was not document; it was not being done and probably never had been done.


The subtlety I was trying to highlight is that in one simple interpretation they are saying ‘audit all your suppliers’. In the past we have used all sorts of risk assessments to define which software suppliers require to be audited and which do not. Now it would appear that the terms mentioned in this interpretation; that contractors and suppliers must be made aware of the precise skills competency and resources that are required of them and that contract givers must have documented evidence that these requirements are within the suppliers capabilities; requires the contract giver to carry out some form of audit in order to establish the requisite documented evidence. How else can you officially approve a supplier.


Alex Kennedy

Last edited by Stijloor; 16th December 2011 at 09:03 AM.
  Post Number #8  
Old 16th December 2011, 09:57 AM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,012
Re: FDA Audit Documentation - Recently released FDA Warning Letter

Quote:
In Reply to Parent Post by alex.Kennedy View Post

I appreciate the comments made by forum readers and I do agree that the universal understanding with regulators was if it was not document; it was not being done and probably never had been done.


The subtlety I was trying to highlight is that in one simple interpretation they are saying ‘audit all your suppliers’. In the past we have used all sorts of risk assessments to define which software suppliers require to be audited and which do not. Now it would appear that the terms mentioned in this interpretation; that contractors and suppliers must be made aware of the precise skills competency and resources that are required of them and that contract givers must have documented evidence that these requirements are within the suppliers capabilities; requires the contract giver to carry out some form of audit in order to establish the requisite documented evidence. How else can you officially approve a supplier.


Alex Kennedy
Every supplier does not require the same level or intensity of audit. The point should be that management PLANS which level of supplier gets what level of audit and then DOCUMENTS that the audit has been conducted at that level and that any and all issues arising from the audit are resolved.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Discussion Forums > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
FDA 483 Warning Letter for use of Calipers jdm2008 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18 10th July 2014 07:00 PM
FDA Form 483 Warning Letter - What next? tallu US Food and Drug Administration (FDA) 7 6th March 2014 12:56 PM
St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues AnaMariaVR2 US Food and Drug Administration (FDA) 5 19th October 2012 04:27 PM
How long does it take US FDA to issue a Warning Letter Close Out Letter Arnthor Other US Medical Device Regulations 1 6th April 2011 03:13 AM
How to Respond to a US FDA untitled letter - Form 483 or Warning Letter Ethan Loh Other US Medical Device Regulations 2 23rd December 2010 09:32 PM



The time now is 12:04 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".