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Page 6 of 42 eBook December 2019 BioPharm International 7 notify them of the need to cor- rect compliance deficiencies. I n s p e c t ion ob s e r v at ion s a r e c r u c i a l , b e c a u s e t h e y d e f i n e t he site's st ate of compl ia nce. Companies that receive 483s are expected to ensure that steps are ta ken to cor rec t problems a nd address the observations and any au x ilia r y systems t hat a re a lso deficient but not cited. The final establishment inspection report (EIR) then determines the result- ing regulatory actions, consider- ing the obser vations, proposed c or r e c t ive me a s u r e s, a nd e v i - dence collected. Three different types of observa- tion classifications (2) are possible: • No Action Indicated (NAI) i nd ic ate s t h at no obje c- t ionable cond it ions were fou nd du r i ng i nsp e c t ion and that no further regula- tory action required. • Voluntary Action Indicated ( VA I ) s how s t h at o bje c- t ionable cond it ions were fou nd, but t he agenc y is not yet willing to take any regulatory action. • Of f ic ia l Ac t ion I nd icated ( OA I ) s h o w s t h a t O R A w i l l re com me nd sp e c i f ic actions. T h i s s t u d y u s e d d at a f r o m F DA's Inspec t ion Classif icat ion Database, which was established in 2009 as part of a transparency initiative (3). The analysis used data classified as final, which is updated by FDA and posted on the agency's website each month. A n y u n d i s c l o s e d i n s p e c t i o n s are not captured in the list. The inspectional observation data set files for years 2014, 2015, 2016, 2017, and 2018 provided the full l i st of aud it obse r vat ion s. For instance, the 2014 list of inspec- t i o n a l o b s e r v a t i o n s i n c l u d e d inspections that ended between Oct. 1, 2013 and Sept. 30, 2014. The data provide a clear indication that most 483 observations were related to Subpart I– laboratory controls. FDA recorded a total of 2997 a u d i t o b s e r v a t i o n s i n 2 0 14 , including 645 Form 483s issued for finished formulation and API sites, which, in turn, were classi- fied into nine categories (4): • Subpart B, organization and personnel • Subpar t C, buildings and facilities • Subpart D, equipment • Subpart E, control of com- ponents and drug product containers and closures • Subpart F, production and process controls • Subpart G, packaging and labeling control • S u b p a r t H , hold i n g a nd distribution • Subpart I, laboratory con- trols • S u b p a r t J , r e c o r d s a n d reports. T he inspec t ion classif icat ion database detailed the number of of f ic ia l a nd volu nt a r y ac t ion s (OAIs and VAIs), whether at US ma nu fac t u r i ng sites or at sites outside of the United States. The authors used the Pearson correlation coefficient to identify Regulatory Sourcebook FDA Inspections Figure 1. Final classified form 483 observations, final drug product and API. 483 (Final Drug Product and API) 730 720 710 700 690 680 670 660 650 640 630 2013 2014 2015 2016 2017 2018 2019 2997 3626 3500 3343 3344 Year 483 (Drug) Observations 2014 645 2997 2015 678 3626 2016 691 3500 2017 694 3343 2018 716 3344 Total 3424 16810 Table I: 483 observations, final drug product and API 2014–2018 ALL FIGURES COURTESY OF THE AUTHORS

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