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FDA’s Accredited Third Party Audtiors

The U.S. Food and Drug Administration (FDA) issued new proposed regulation for the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP), in agreement with section 301 of the Food Safety Modernization Act (FSMA). FDA asks interested parties to comment on various aspects of the proposed regulation.

The notice and comment process enables anyone to submit a comment on any part of the proposed rule. FDA bases its reasoning and conclusions on the rulemaking record, consisting of the comments, scientific data, expert opinions, and facts accumulated during the pre-rule and proposed rule stages. To publish a final rule, FDA must conclude that its proposed solution will help accomplish the goals or solve the problems identified. FDA must also determine whether alternate solutions would be more effective or cost less.

An central issue of FSVP for which FDA has asked for comment is if third-party auditors should be accredited in the future (since the existing FSVP proposal DOES NOT require accredited third-party auditors):

“FDA believes that it would be acceptable for an importer to rely on an audit conducted by a third-party auditor who is a qualified individual but is not accredited in accordance with section 808. FDA requests comment on whether, at some future date and/or under particular circumstances, importers should no longer be permitted to rely on third-party auditors who are not accredited in accordance with section 808 to conduct onsite audits or other FSVP activities.”

Comments regarding the question of FDA FSVP requiring accredited third-party auditors in the future must be submitted by November 26, 2013. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

You may submit comments on the proposed Foreign Supplier Verification Program rule, identified by Docket No. FDA-2011-N-0143 and/or Regulatory Information Number (RIN) 0910-AG64 at this link: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0143-0023

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