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FDA has issued three Warning Letters...

M

MIREGMGR

#11
#11
Sidney Vianna said:
Can a voluntary program be really rigorous?
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Yes if it's truly voluntary, and the only benefit of it is a marketing stance.

Let's look at the voluntary accredited management system certification programs for standards such as ISO 9001, ISO 14001, ISO 13485, etc.
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ISO 13485 isn't voluntary if I as a US manufacturer want to market medical devices in the EU. ISO 13485 is effectively a pre-requisite for CE Mark, which is mandated.

Does Industry keep substandard suppliers and CB's accountable?
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"Accountable" is a slippery term, because the applicable standards as officially interpreted and applied are not sufficient to actually amount to excellent performance.

I still think that a potential solution could be a layer of additional oversight, which I explained when I created the Should Regulatory Agencies require Accredited Certification in their Respective Areas? thread.
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I don't want to see any change that requires anyone to participate. I'd much rather see a two-tier system, with the current so-so mandatory regulation and a higher tier.

Recall the Good Housekeeping Seal of Approval. AFAIK that was never linked to a formal quality system, but at least at the beginning you did have to offer superior products and customer service to get it and keep it. There have been several more recent attempts to create a voluntary mark, mostly in the "green" areas. That's what I want...a heavily marketed, IP-protected quality system that indicates we go well beyond what the FDA regards as tolerable.
 
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pkost

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#12
#12
Jim Wynne

Jim Wynne

Staff member
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#13
#13
pkost said:
This has got to be the best warning letter yet: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm274540.htm

for failure to establish and maintain procedures for implementing CAPA, design control, purchasing, document control, audit etc etc
Upon request by the investigator for the above referenced procedures, you indicated the requested procedures were located in your head.
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And his head was located in a different part of his anatomy. :tg:
 
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