33 App. 204. 34 This is significant because such a report is required under 21 U.S.C. 374: Upon completion of any such inspection [for which an FDA-482 is issued] of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the prem- ises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary condi- tions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.

.5 21 U.S.C. § 352 ................................................................................................................................5 21 U.S.C. § 360(h) ...........................................................................................................................5 21 U.S.C. § 360c(a)(1) .....................................................................................................................2 21 U.S.C. § 360e(d) ...................................................................................................................2, 16 21 U.S.C. § 360e(d)(6)(A)(i) ...........................................................................................................3 21 U.S.C. § 360k(a) ............................................................................................................... passim 21 U.S.C. § 360k(a)(1) .............................................................................................................13, 14 21 U.S.C. § 374 ................................................................................................................................5 TEX. BUS.