{"id":1529,"date":"2020-01-23T10:58:29","date_gmt":"2020-01-23T17:58:29","guid":{"rendered":"https:\/\/marianboardley.com\/blog\/?p=1529"},"modified":"2020-01-23T10:58:29","modified_gmt":"2020-01-23T17:58:29","slug":"time-to-review-your-foreign-supplier-fsvp-program","status":"publish","type":"post","link":"https:\/\/marianboardley.com\/blog\/time-to-review-your-foreign-supplier-fsvp-program\/","title":{"rendered":"Time to review your foreign supplier (FSVP) program?"},"content":{"rendered":"

\"FSMA<\/a><\/p>\n

The FSVP regulation requires importers to perform certain risk-based activities to verify that human or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.<\/p>\n

Recently I have noticed several FDA Warning Letters<\/a> for FSVP inspections.\u00a0 FDA appears now to be conducting FSVP-specific inspections, for example, in one letter they state:<\/p>\n

“On June 28, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at your facility….This inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the Foreign Supplier Verification Program (FSVP) implementing regulation in 21 CFR part 1 subpart L.<\/em>”<\/p>\n

and, notably:<\/p>\n

“At the conclusion of the inspection our investigator provided you with a Form FDA 483a, FSVP Observations.”<\/em><\/p>\n

There seems to be a specific Form 483a which is used for these inspections.\u00a0 However, a search at FDA.gov did not yield a example of this form. For calendar year 2019, I found 315 citations in FDA’s citations database<\/a> for failure to develop Foreign Supplier Verification Programs.<\/p>\n

See the full-resolution chart of 2019 FDA 21 CFR Part One citations (includes FSVP inspections) [PDF]: https:\/\/www.marianboardley.com\/charts\/21%20cfr%201.pdf<\/a><\/p>\n

If you import ingredients, dietary supplements or foods, 2020 might be a good time to get your foreign supplier verification program on track, or take FSVP training!<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The FSVP regulation requires importers to perform certain risk-based activities to verify that human or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. Recently I have noticed several FDA Warning Letters for FSVP inspections.\u00a0 FDA appears now to be conducting FSVP-specific inspections, … Continue reading Time to review your foreign supplier (FSVP) program?<\/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-1529","post","type-post","status-publish","format-standard","hentry","category-charts"],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p2Lzp2-oF","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/1529","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=1529"}],"version-history":[{"count":8,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/1529\/revisions"}],"predecessor-version":[{"id":1544,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/posts\/1529\/revisions\/1544"}],"wp:attachment":[{"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/media?parent=1529"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/categories?post=1529"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/marianboardley.com\/blog\/wp-json\/wp\/v2\/tags?post=1529"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}