A review of FDA citations for 21 CFR 211.42 Subpart C Buildings and Facilities over the past 5 years (2018-2014) from the FDA Turbo data was conducted by Performance Validation. Our analysis identified that the highest frequency of citations within the buildings and facilities subpart were consistently attributed to two code sections:
The citations to these two sections are illustated below for the past 5-years.
These two citations have historically accounted for ~50-60% of all the citations generated to the buildings and facilities subpart. The most common descriptions from the FDA for these two items are:
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