FY 2014 FDA Inspection Observations data mostly followthe trends established in 2012 and 2013, apart from the total number ofobservations. As usual, the ‘live’ data can be found on following web site at
除了缺陷总数以外,2014年FDA检查缺陷数据趋势和2013年及2014年相近,通常,在下网站可以找到“动态”数据。
http://www.marianboardley.com/charts
The total number of 21 CFR 111 cGMP observationsfor FDA FY 2014 under the dietary supplement cGMP’s has declined, to~1500 in 2014 compared with ~2200 in FY2013 (based on 2476 Form 483’s issuedfor Foods, including dietary supplements)
The number of Subpart E observations is >30% of thetotal observations for FY 2014 (this has been growing annually).
In FY 2014, FDA issued more citations for 21 CFR 111.70(e) [specifications– identity, purity, strength and composition] than for 21 CFR 111.75(a)(1)(i)[component – verify identity dietary ingredient ] but the latter continues tobe very important in inspections as the second most cited in 2014. See
http://www.marianboardley.com/charts/subpart-items.php?Year=2014&Subpart=E (also http://www.marianboardley.com/charts/stacked_bar_chart.phpfor trends in top observations)
FDA’s focus on complaints has continued in FY2014.Subpart O – Product Complaints is in 5th place, behind subparts E, I, F and H. Production and process control,quality control, master manufacturing and batch records account for a largepart of the total observations.
Lack of written procedures for quality controloperations continues to be an important issue for inspectors. See http://www.marianboardley.com/charts/subpart-items.php?Year=2014&Subpart=F
In FY 2014, FDA again called out the need for adequatecriteria for selecting standard reference materials used in laboratoryoperations [111.315(d)]. See http://www.marianboardley.com/charts/subpart-items.php?Year=2014&Subpart=J
排名前6位的缺陷项目如下: