CFR section
21 CFR 600.14(a)(1): Reporting of biological product deviations by licensed manufacturers
PART 600-BIOLOGICAL PRODUCTS: GENERAL · Subpart B-Establishment Standards
Key facts
| Citation | 21 CFR 600.14(a)(1) |
|---|---|
| Section | Reporting of biological product deviations by licensed manufacturers |
| Part | PART 600-BIOLOGICAL PRODUCTS: GENERAL |
| Subpart | Subpart B-Establishment Standards |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Devices, Drugs, General |
| Regulation text (excerpt) | (1) You, the manufacturer who holds the biological product license and 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 follow a procedure for receiving information from that person on all deviations, complaints, and adverse events concerning the… |
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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.