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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 600 — BIOLOGICAL PRODUCTS: GENERAL
Subpart B — Establishment Standards
Federal (United States) · Regulations
Subpart B — Establishment Standards
6 sections
6 sections
21 C.F.R. § 600.10
Personnel.
21 C.F.R. § 600.11
Physical establishment, equipment, animals, and care.
21 C.F.R. § 600.12
Records.
21 C.F.R. § 600.13
Retention samples.
21 C.F.R. § 600.14
Reporting of biological product deviations by licensed manufacturers.
21 C.F.R. § 600.15
Temperatures during shipment.
Subpart B — Establishment Standards | Federal (United States) Regulations | Justis AI