Part 600 Biological Products: General

Subpart A - General Provisions

• § 600.2   Mailing addresses
• § 600.3   Definitions

Subpart B - Establishment Standards

• § 600.10   Personnel 41 × 483
• § 600.11   Physical establishment, equipment, animals, and care 8 × 483
• § 600.12   Records 33 × 483
• § 600.13   Retention samples
• § 600.14   Reporting of biological product deviations by licensed manufacturers 87 × 483
• § 600.15   Temperatures during shipment 13 × 483

Subpart C - Establishment Inspection

• § 600.20   Inspectors
• § 600.21   Time of inspection
• § 600.22   § 600.22 [Reserved] removed

Subpart D - Reporting of Adverse Experiences

• § 600.80   Postmarketing reporting of adverse experiences 27 × 483
• § 600.81   Distribution reports 1 × 483
• § 600.82   Notification of a permanent discontinuance or an interruption in manufacturing
• § 600.90   Waivers