CFR section
21 CFR 606.160(b): Records
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart I-Records and Reports
Key facts
| Citation | 21 CFR 606.160(b) |
|---|---|
| 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) | (b) Records shall be maintained that include, but are not limited to, the following when applicable: (1) Donor records: (i) Donor selection, including medical interview and examination and where applicable, informed consent. (ii) Permanent and temporary deferrals for health reasons including reason(s) for deferral. (iii) Donor adverse reaction complaints and reports, including results of all investigations and followup. (iv) Therapeutic bleedings, including signed requests from attending… |
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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.