Increase Continues In Supplement GMP Noncompliance
This article was originally published in The Tan Sheet
Executive Summary
The GMP noncompliance rate in the dietary supplement industry continued to increase in the first quarter of fiscal 2014 after reaching nearly 70% in fiscal 2013.
The good manufacturing practices noncompliance rate in the dietary supplement industry continued to increase in the first quarter of fiscal 2014, from 69.4% for all of 2013 to 72.1% in the October-December period of 2013, according to FDA’s Division of Dietary Supplement Programs data (see story, (Also see "Inspection Data Show “Reality” Of Supplement GMP Enforcement" - Pink Sheet, 21 Apr, 2014.)).
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FDA Supplement GMP Inspections* |
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|
Fiscal Year |
Inspections |
% Found Noncompliant |
% Official Action Indicated |
% Voluntary Action Indicated |
% No Action Indicated |
|
2008 |
158 |
41.1 |
15.2 |
25.9 |
58.9 |
|
2009 |
162 |
43.2 |
14.8 |
28.4 |
56.8 |
|
2010 |
228 |
61.4 |
25.4 |
36 |
38.6 |
|
2011 |
353 |
75.0 |
36.8 |
38.2 |
30.6 |
|
2012 |
591 |
63.8 |
27.9 |
35.9 |
34.5 |
|
2013 |
585 |
69.4 |
28 |
41.4 |
30.6 |
|
2014 (Q1) |
140 |
72.1 |
34.3 |
37.8 |
27.9 |
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* FDA officials reported these figures as preliminary; from April 15 presentation at the International Conference on the Science and Regulation of Botanicals. |
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