CFR section
21 CFR 606.160(a)(2): Records
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart I-Records and Reports
Key facts
| Citation | 21 CFR 606.160(a)(2) |
|---|---|
| Section | Records |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart I-Records and Reports |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (2) Appropriate records shall be available from which to determine lot numbers of supplies and reagents used for specific lots or units of the final product. |
At a glance
- 10–99 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.