Common use of FDA Regulatory Clause in Contracts

FDA Regulatory. (a) Each Loan Party complies, and has complied since its inception, in all material respects with the FDA Laws. The foregoing includes any applicable good manufacturing practices and sanitation requirements, labeling and advertising requirements, requirements relating to food or color additives, food standards, product composition requirements, testing requirements or protocols, recordkeeping or reporting requirements, monitoring requirements, packaging (including co-packing and re-packing) requirements, laboratory controls, storage and warehousing procedures, shipping requirements, import and export requirements, supply chain security, food handling, and shelf-life requirements. No Loan Party has received any notification asserting, nor does any Loan Party have knowledge of, any failure to comply with or violation of the FDA Laws. (b) Neither any Loan Party nor any of its respective facilities has received any FDA Form 483s, Notices of Adverse Findings, Warning Letters, untitled letters or other correspondence or notice from the FDA or any other Governmental Authority alleging or asserting material noncompliance with any FDA Laws. No Loan Party has received any written or oral notice that the FDA or any other Governmental Authority has commenced, or threatened to initiate, any action to revoke such Loan Party’s registration, to request a recall, or to halt distribution of any of such Loan Party’s products, or commenced or threatened to initiate any action to seize, or enjoin the production of, any of such products. Neither any Loan Party nor its respective facilities are subject to consent decrees. (c) No Loan Party has, either voluntarily or involuntarily, initiated, conducted, or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, or other notice or action relating to the alleged lack of safety of any product or any alleged product defect or violation. Each Loan Party has established and administers a food safety compliance program, including but not limited to, a written food safety plan and food defense plan applicable to such Loan Party, to assist such Loan Party and the directors, officers and employees of such Loan Party in complying with FDA Laws. (d) No Loan Party has failed to file with the applicable Governmental Authority any filing, declaration, listing, registration, report or submission required by the FDA Laws; all such filings, declarations, listing, registrations, reports or submission were in compliance with applicable FDA Laws when filed and no deficiencies have been asserted by any applicable regulatory authority. Neither any Loan Party nor any officer, employee or agent of such Loan Party has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority with substantially similar regulatory responsibilities, or failed to disclose a material fact required to be disclosed to any Governmental Authority. (e) All “organic” goods that any Loan Party produces, manufactures, packs, holds, markets, and/or sells are processed, tested, stored, handled, transported, and delivered in accordance with standards that meet or exceed the: (i) the Organic Foods Production Act of 1990; (ii) 7 C.F.R. Section 205, et seq. (USDA Organic standards); (iii) verification from a USDA-accredited certifying agent, dated January 1, 2013 or later; and (iv) any comparable applicable state laws or regulations.