CFR section
21 CFR 610.18(b): Cultures
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart B-General Provisions
Key facts
| Citation | 21 CFR 610.18(b) |
|---|---|
| Section | Cultures |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart B-General Provisions |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs, Other_Regulations |
| Regulation text (excerpt) | (b) Identity and verification. Each culture shall be clearly identified as to source strain. A complete identification of the strain shall be made for each new stock culture preparation. Primary and subsequent seed lots shall be identified by lot number and date of preparation. Periodic tests shall be performed as often as necessary to verify the integrity of the strain characteristics and freedom from extraneous organisms. Results of all periodic tests for verification of cultures and… |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.