Category Archives: Charts

FDA Releases New TurboEIR (483) Data

I’m pleased to announce that FDA has posted the Turbo EIR data for inspection observations (483’s) for FY 2011 & FY 2012.

I will be working on some new charts in the next couple weeks, but here is some preliminary data.  As you can see, ‘Component –  verify identity, dietary ingredient’ — aka 21 CFR 111.75(a)(1)(i) — became an even bigger issue during 2012 inspections than in previous years, and now leads as the most cited item for all years combined (for inspections under 21 CFR 111 GMP’s.)  Having proper SOP’s in place for product complaints and QC operations remains a big priority, along with complete specifications/MMR/BPR and supplier qualification.

There were a total of 1964 21 CFR 111 observations entered into the FDA TurboEIR system in 2012, compared with 1328 (2011); 631 (2010); 130 (2009).

Top 483 observations FY 2008 – 2012 total:

Description
Total Observations
Component –  verify identity, dietary ingredient106
Specifications – identity, purity, strength, composition95
Written procedures – product complaint93
Written procedures – quality control operations91
Component – qualify supplier80
Batch record – complete78
Specifications met – verify; finished batch71
Master manufacturing record – unique formulation67
Master manufacturing record – each batch66
Written procedures – holding54
Specifications-component purity, strength, composition54

See http://www.fda.gov/iceci/EnforcementActions/ucm250720.htm for more information about this data and how it is gathered.