CFR section
21 CFR 606.171(a): Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services
PART 606-CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS · Subpart I-Records and Reports
Key facts
| Citation | 21 CFR 606.171(a) |
|---|---|
| Section | Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services |
| 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) | (a) Who must report under this section? You, a licensed manufacturer of blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the product when the deviation occurred, must report under this section. If you arrange for another person to perform a manufacturing, holding, or distribution step, while the product is in your control, that step is performed under your control. You must establish, maintain, and… |
At a glance
- 10–99 Inspections citing this section
- None 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.