Are CMG liquefaction plants and container filling facilities required to register with FDA as drug manufacturers?
Yes, a drug registration form must be submitted to FDA for every liquefaction plant and for every container filling facility. Furthermore, a drug listing form must be submitted to FDA listing each compressed medical gas filled or relabeled at that facility. Drug registration and drug listing forms can be obtained from any FDA District Office (see attached list). 3. QUESTION: How often are such plants inspected by FDA? ANSWER: The Act requires FDA to inspect each liquefaction plant and each container filling facility at least once every two years. However, more frequent inspections may be made for several reasons; such as to investigate an industry or consumer complaint, product recall, or as a follow-up to a Warning Letter. 4. QUESTION: What are FDA investigators authorized to inspect? ANSWER: FDA investigators are authorized to enter a drug manufacturer’s place of business to inspect the buildings, equipment, finished and unfinished materials, containers, and labeling. In the case of
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