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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter FPart 600Subpart C → §600.21


Title 21: Food and Drugs
PART 600—BIOLOGICAL PRODUCTS: GENERAL
Subpart C—Establishment Inspection


§600.21   Time of inspection.

The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.

[38 FR 32048, Nov. 20, 1973, as amended at 48 FR 26314, June 7, 1983; 64 FR 56449, Oct. 20, 1999; 84 FR 12508, Apr. 2, 2019]

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