; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant adverse health condition, disability, or incapacity; (v) congenital anomaly or birth defect; or (vi) significant disfigurement, including serious or persistent rashes and infections, burns, or significant hair loss; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A). . 105. Records inspection; mandatory recall authority Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.), as amended by section 104, is further amended by adding at the end the following: 612. Inspection of cosmetic records (a) Inspection of records Each facility, including a facility owned or operated by a responsible person for a cosmetic product shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy, or receive electronically records maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location, including— (1) all records maintained under section 611 and in accordance with the rules promulgated by the Secretary under section 610, as applicable; (2) all records maintained under section 609; (3) any records relating to the list of ingredients in specific fragrances or flavors of a cosmetic product or cosmetic formulation, if requested by the Secretary by means of a written notification