21 CFR § 600.21 Biological Products: General

§ 600.21 Time of inspection.

Current through Sep 8, 2026 · Read all of Part 600

⚠ 2 pending changes to Part 600

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]

← § 600.20 Inspectors.§ 600.22 [Reserved] →