CFR section
21 CFR 606.100(b)(21): Standard operating procedures
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart F-Production and Process Controls
Key facts
| Citation | 21 CFR 606.100(b)(21) |
|---|---|
| Section | Standard operating procedures |
| Part | PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS |
| Subpart | Subpart F-Production and Process Controls |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs |
| Regulation text (excerpt) | (21) Procedures for donor notification and notification of the referring physician of an autologous donor, including procedures for the appropriate followup if the initial attempt at notification fails, as prescribed in § 630.40 of this chapter. |
At a glance
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- 1–9 Warning letters citing this section
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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.