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The 483 is quite comprehensive and can almost be used as a checklist in preparation for FDA inspections.
W-074 Cleaning validation studies for the multi-use process equipment were inadequate in that l The cleaning procedure did not specify the quantity and time for rinsing thee ...
machine components therefore any organic residue found can not be quantified l Swab sampling was not representative of the total surface area ..., no recovery data for swab samples was available.
W-044 W-006 No written procedures that would clearly define and describe the responsibilities and procedures applicable to the quality control functions associated with the manufacture of this product.
This was the largest ever assessed on an FDA regulated company.
The decree affects about more than 100 different prescription and over-the-counter drugs as part of the decree, the company has agreed to suspend manufacturing 73 other products (Ref: Validation Times, May 21, 2002).
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Important: Warning letters should be interpreted in the context of full content. And sometimes they include good advice from the FDA not mentioned in the extract.
Most useful is to have the 483, the EIR, and the warning letter from the same inspection.
When thoroughly read this information is ideal to prepare firms for inspections.
It is an opportunity for us to reflect on the language and ideas that represented each year.