{"id":1480,"date":"2019-07-30T14:07:54","date_gmt":"2019-07-30T20:07:54","guid":{"rendered":"https:\/\/marianboardley.com\/blog\/?p=1480"},"modified":"2019-07-30T14:07:54","modified_gmt":"2019-07-30T20:07:54","slug":"latest-fda-citations-data-fsma","status":"publish","type":"post","link":"https:\/\/marianboardley.com\/blog\/latest-fda-citations-data-fsma\/","title":{"rendered":"Latest FDA Citations Data – FSMA"},"content":{"rendered":"
\"\"<\/a>
FSMA cGMPs – 21 CFR 117 citations<\/figcaption><\/figure>\n

I just updated the charts<\/a> with fresh data from FDA.\u00a0 Most food inspections are now occurring under new FSMA cGMPs (at 21 CFR 117) with the number of citations under the old food cGMPs being minimal.<\/p>\n

Drilling down on the detail FSMA chart<\/a> shows an increasing number of FDA 483s now contain observations related to hazard analysis and preventive controls. *Note: FDA FY 2019 ends on 9\/30\/19, the data are current as of 7\/17\/19)<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Subpart<\/th>\nDescription<\/th>\n# Citations (FDA Fiscal YEAR 2019* to-date)<\/th>\n<\/tr>\n<\/thead>\n
B<\/td>\n117.35 – Sanitary operations.<\/td>\n355<\/td>\n<\/tr>\n
B<\/td>\n117.80 – Processes and controls.<\/td>\n189<\/td>\n<\/tr>\n
B<\/td>\n117.10 – Personnel.<\/td>\n127<\/td>\n<\/tr>\n
B<\/td>\n117.20 – Plant and grounds.<\/td>\n119<\/td>\n<\/tr>\n
B<\/td>\n117.40 – Equipment and utensils.<\/td>\n110<\/td>\n<\/tr>\n
C<\/td>\n117.130 – Hazard analysis.<\/td>\n77<\/td>\n<\/tr>\n
C<\/td>\n117.145 – Monitoring.<\/td>\n69<\/td>\n<\/tr>\n
C<\/td>\n117.135 – Preventive controls.<\/td>\n66<\/td>\n<\/tr>\n
B<\/td>\n117.37 – Sanitary facilities and controls.<\/td>\n64<\/td>\n<\/tr>\n
A<\/td>\n117.4 – Qualifications of individuals who manufacture, process, pack, or hold food.<\/td>\n54<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

In addition, firms are being cited for new foreign supplier regulations (FSVP) under 21 CFR Part 1 (see below).\u00a0 This rule applies to all importers of food, including dietary supplement ingredients.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
CFR #<\/th>\nShort Description<\/th>\nLong Description<\/th>\nFrequency (TOTAL FOR ALL FISCAL YEARS)<\/th>\n<\/tr>\n<\/thead>\n
1.502(a)<\/a><\/td>\nDevelop FSVP<\/td>\nYou did not develop an FSVP.<\/td>\n509<\/td>\n<\/tr>\n
1.225<\/a><\/td>\nNot registered<\/td>\nYour food facility is not registered as required.<\/td>\n33<\/td>\n<\/tr>\n
1.512(b)(2)<\/a><\/td>\nDevelop FSVP<\/td>\nYou did not develop an FSVP.<\/td>\n31<\/td>\n<\/tr>\n
1.504(a)<\/a><\/td>\nHazard analysis written<\/td>\nYou did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards.<\/td>\n25<\/td>\n<\/tr>\n
1.505(b)<\/a><\/td>\nSupplier approval – document<\/td>\nYou did not document your approval of your foreign supplier.<\/td>\n23<\/td>\n<\/tr>\n
1.506(a)(1)<\/a><\/td>\nProcedures – establish, approve supplier<\/td>\nYou did not establish written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food.<\/td>\n22<\/td>\n<\/tr>\n
1.504(a)<\/a><\/td>\nHazard analysis written<\/td>\nYou did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control.<\/td>\n19<\/td>\n<\/tr>\n
1.505(a)(2)<\/a><\/td>\nEvaluation – performance, risk<\/td>\nYou did not document the evaluation you conducted to determine a foreign supplier’s performance and the risk posed by a food.<\/td>\n13<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

I just updated the charts with fresh data from FDA.\u00a0 Most food inspections are now occurring under new FSMA cGMPs (at 21 CFR 117) with the number of citations under the old food cGMPs being minimal. Drilling down on the detail FSMA chart shows an increasing number of FDA 483s now contain observations related to … Continue reading Latest FDA Citations Data – FSMA<\/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":[15,19,30,29,20,17],"class_list":["post-1480","post","type-post","status-publish","format-standard","hentry","category-charts","tag-cgmps","tag-fda-form-483","tag-food-safety","tag-fsma","tag-inspections","tag-suppliers"],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p2Lzp2-nS","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/1480","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=1480"}],"version-history":[{"count":3,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/1480\/revisions"}],"predecessor-version":[{"id":1484,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/1480\/revisions\/1484"}],"wp:attachment":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/media?parent=1480"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/categories?post=1480"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/tags?post=1480"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}