(1) The department may require a facility that engages in the manufacture, retail sale, or wholesale distribution of medical gas to undergo an inspection in accordance with a schedule to be determined by the department, including inspections for initial permitting, permit renewal, and a permitholder’s change of location. The department may recognize a third party to inspect wholesale distributors in this state or other states pursuant to a schedule to be determined by the department.
(2) The department may recognize another state’s inspections of a manufacturer or wholesale distributor located in that state if such state’s laws are deemed to be substantially equivalent to the laws of this state by the department.
(3) A manufacturing facility of medical gases is exempt from routine inspection by the department if:(a) The manufacturing facility is currently registered with the United States Food and Drug Administration under s. 510 of the federal act and can provide proof of registration, such as a copy of the Internet verification page; and
(b) The manufacturing facility can provide proof of inspection by the Food and Drug Administration, or if the facility is located in another state, inspection by the Food and Drug Administration or other governmental entity charged with regulation of good manufacturing practices related to medical gases in that state within the past 3 years, which demonstrates substantial compliance with current good manufacturing practices applicable to medical gases.
(4) A permitholder under this part shall exhibit or have readily available its state permits and its most recent inspection report administered by the department.
