The Top 12 FDA 2011 Warning Letters Report

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QA Systems Manager

#3
so, may I ask why these are the top ten? Thanks for the efforts at looking at and posting!
 

v9991

Trusted Information Resource
#4
Ningbo Smart Pharmaceutical:- wrt QC testing & release - specifications -
Yag-Mag Labs:- wrt online documentation - design & mfg contols - cross contamination - document & material controls
Golden State Medical Supply:- wrt investigations (RCA - CAPA)- stability studies - material/product controls -
Daiichi Sankyo/Luitpold Pharmaceuticals/American Regent :- wrt APR-incidents -investigations - material controls - equipment calibration - qualification
Jelfa Pharmaceutical: wrt investigations - microbial contaminations-qa/qc responsibilities -
Sichuan Pharmaceutical: wrt cross contamination
Dr. Reddy's Mexico: wrt product & process validations - OOS investigations - QA release procedures
L. Perrigo: wrt specifications - qc criteria - investigations (RCA - CAPA) - SOP compliance in QC/ material.product-release criteria
Hawkeye-Jensen: wrt cleaning+maintenance - qualification & validations - complaints & QCU - testing & specifications/methods -
Scientific Protein Laboratories : wrt complaints + investigations - contract laboratory - qualification of equipment(design) - supplier assessment
Baxter Healthcare : wrt investigations(RCA - CAPA ) - container closure system + back up & labelling informations (linking labelling information with CPP-CQAs-CMA this is just my interpretation) - post marketing issues
Klinge Chemicals : wrt water system - stability studies and QC/QA overview on standards of testing and batch release.
forgive me for being broad&cryptic in representation of key areas; but the idea is to emphasize the
1) key-repeated-gaps being "identifying&reporting incidents - qualifications & validations (both material - equipment - process) - investigations(RCA & CAPA)
2) most observations are(at least 60:40) are about having system not adequately&complete following (there are fewer things about not having system itself...i guess)

BTW,
Would it be correct to say that, warning letters signify the firms inability to comprehensively & timely address the observations; hence 483s are more of reflective of agencies priorities & focus?
 
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v9991

Trusted Information Resource
#6
forgive me for being broad&cryptic in representation of key areas; but the idea is to emphasize the
1) key-repeated-gaps being "identifying&reporting incidents - qualifications & validations (both material - equipment - process) - investigations(RCA & CAPA)
2) most observations are(at least 60:40) are about having system not adequately&complete following (there are fewer things about not having system itself...i guess)

BTW,
Would it be correct to say that, warning letters signify the firms inability to comprehensively & timely address the observations; hence 483s are more of reflective of agencies priorities & focus?


corollary to that point is ...
well it looks like, what can be inferred from 483s/warning letters is that; more than 50% of cases are to do with the ""lack of application/execution/compliance"" of SOPs; but 90% of industry seems to be running towards having a SOP in place;

on contrary, all the discussions are running towards the having a flawless/comprehensive SOP;
surprising thing is that very few discussions on making the things complete.(complete - comprehensive discussions on application-implementation-execution of various problems)

what I am trying to say here is that;
if you take common problems outlined such as investigations (RCA - CAPA), how many discussion do we see discussing the problem of water system product-OOS/NCs; (vs discussion on SOP for water system validation which is very generic level)

its time to start discussing (atleast at generic level) the specific problems and approach to investigations;

there ought to be general templates (viz, fish bone diagrams, failure modes) etc., available for most of unit operations.
but we seldom see them in open domain.

instead of laying emphasis on finding lasting solutions (non-repeating action); another area where emphasis is misplaced is that 'control' endowed in the name of "documentation" or "QA function".(this is true atleast for pharma);

apart from other reasons, that is probably one reason why pharma is left behind in the race of quality-concepts and tools.

hope to hear your thoughts.
 
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v9991

Trusted Information Resource
#8
forgive me for being broad&cryptic in representation of key areas; but the idea is to emphasize the
1) key-repeated-gaps being "identifying&reporting incidents - qualifications & validations (both material - equipment - process) - investigations(RCA & CAPA)
2) most observations are(at least 60:40) are about having system not adequately&complete following (there are fewer things about not having system itself...i guess)

BTW,
Would it be correct to say that, warning letters signify the firms inability to comprehensively & timely address the observations; hence 483s are more of reflective of agencies priorities & focus?
here's another (latest )example
latest warning letter from FDA focussing on RCA - CAPA - Complaints... & they are more on implementation-conclusions and less on systems/procedures)
(almost 7 out of 10 issues cited are related above topics)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm283476.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm281843.htm

this is more understandable when u see the look at series of warning letters to same organization...
 
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