CFR section
21 CFR 212.100(a): What do I do if I receive a complaint about a PET drug product produced at my facility?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart K-Complaint Handling
Key facts
| Citation | 21 CFR 212.100(a) |
|---|---|
| Section | What do I do if I receive a complaint about a PET drug product produced at my facility? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart K-Complaint Handling |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs |
| Regulation text (excerpt) | (a) Written complaint procedures. You must develop and follow written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product. |
At a glance
- 10–99 Inspections citing this section
- 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.