Common use of FDA Regulatory Matters Clause in Contracts

FDA Regulatory Matters. 3.21.1 The Company and its Subsidiaries are, and since January 1, 2018, have at all times been, in compliance with all FDA Laws as applied to the conduct of its business, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. 3.21.2 Neither the Company nor any of its Subsidiaries has received any written Form FDA-483, notice of adverse finding, warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other written notice from the FDA or any other Governmental Entity. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, the Company and each Subsidiary has made all notifications, submissions, responses and reports required by FDA Laws or any other Law, including such obligation arising under any administrative, enforcement or regulatory action, inspection, warning letter, notice of violation letter, or other notice, response or commitment made to or with the FDA or any comparable Governmental Entity and all such notifications, submissions and reports were correct and complete in all material respects as of the date of submission to the FDA or any comparable Governmental Entity. 3.21.3 To the Knowledge of the Company, no product distributed or sold by or on behalf of the Company or any Subsidiary has been either voluntarily or involuntarily seized, withdrawn, recalled, detained or subject to a suspension of manufacturing or sale as a result of a violation of an FDA Law.