{"id":304,"date":"2014-12-03T14:45:40","date_gmt":"2014-12-03T21:45:40","guid":{"rendered":"https:\/\/marianboardley.com\/blog\/?p=304"},"modified":"2014-12-17T18:50:24","modified_gmt":"2014-12-18T01:50:24","slug":"new-fda-observations-data-for-fy-2014-released","status":"publish","type":"post","link":"https:\/\/marianboardley.com\/blog\/new-fda-observations-data-for-fy-2014-released\/","title":{"rendered":"New FDA Observations Data for FY 2014 Released"},"content":{"rendered":"
\"2014<\/a>
FY 2014 FDA 483 Observations<\/figcaption><\/figure>\n

FY 2014 FDA Inspection Observations data mostly follow the trends established in 2012 and 2013, apart from the total number of observations. As usual, the \u2018live\u2019 data can be found on my web site at http:\/\/www.marianboardley.com\/charts<\/a><\/p>\n

    \n
  1. The total number of 21 CFR 111 cGMP observations<\/strong> for FDA FY 2014 under the dietary supplement cGMP\u2019s<\/strong> has declined, to ~1500 in 2014 compared with ~2200 in FY2013 (based on 2476 Form 483\u2019s issued for Foods, including dietary supplements)<\/li>\n
  2. The number of Subpart E observations is >30% of the total observations for FY 2014 (this has been growing annually).<\/li>\n
  3. 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 \u2013 verify identity dietary ingredient ] but the latter continues to be very important in inspections as the second most cited in 2014. See http:\/\/www.marianboardley.com\/charts\/subpart-items.php?Year=2014&Subpart=E<\/a>\u00a0 (also http:\/\/www.marianboardley.com\/charts\/stacked_bar_chart.php<\/a> for trends in top observations)<\/li>\n
  4. FDA\u2019s focus on complaints has continued in FY2014. Subpart O \u2013 Product Complaints is in 5th<\/sup> place, behind subparts E, I, F and H. Production and process control, quality control, master manufacturing and batch records account for a large part of the total observations.<\/li>\n
  5. Lack of written procedures for quality control operations continues to be an important issue for inspectors. See http:\/\/www.marianboardley.com\/charts\/subpart-items.php?Year=2014&Subpart=F<\/a><\/li>\n
  6. In FY 2014, FDA again called out the need for adequate criteria for selecting standard reference materials used in laboratory operations [111.315(d)]. See http:\/\/www.marianboardley.com\/charts\/subpart-items.php?Year=2014&Subpart=J<\/a><\/li>\n<\/ol>\n

    Original data: http:\/\/www.fda.gov\/ICECI\/Inspections\/ucm250720.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

    FY 2014 FDA Inspection Observations data mostly follow the trends established in 2012 and 2013, apart from the total number of observations. As usual, the \u2018live\u2019 data can be found on my web site at http:\/\/www.marianboardley.com\/charts The total number of 21 CFR 111 cGMP observations for FDA FY 2014 under the dietary supplement cGMP\u2019s has … Continue reading New FDA Observations Data for FY 2014 Released<\/span> →<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-304","post","type-post","status-publish","format-standard","hentry","category-charts"],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p2Lzp2-4U","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/304","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/comments?post=304"}],"version-history":[{"count":7,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/304\/revisions"}],"predecessor-version":[{"id":316,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/304\/revisions\/316"}],"wp:attachment":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/media?parent=304"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/categories?post=304"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/tags?post=304"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}