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 ingredient | 106 |
| Specifications – identity, purity, strength, composition | 95 |
| Written procedures – product complaint | 93 |
| Written procedures – quality control operations | 91 |
| Component – qualify supplier | 80 |
| Batch record – complete | 78 |
| Specifications met – verify; finished batch | 71 |
| Master manufacturing record – unique formulation | 67 |
| Master manufacturing record – each batch | 66 |
| Written procedures – holding | 54 |
| Specifications-component purity, strength, composition | 54 |
See http://www.fda.gov/iceci/EnforcementActions/ucm250720.htm for more information about this data and how it is gathered.