facility
- Guideline or reference source
- FDAGDUFA Generic Drug User Fee Amendments 2012
- Definition
- business or other entity under one management either direct or indirect and at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form, but does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing. For purposes of this definition, separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are closely related to the same business enterprise, under the supervision of the same local management, and are capable of being inspected by the Food and Drug Administration during a single inspection.
- Narrower Term
- contract facility
- self-contained facility
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