CFR section
21 CFR 212.71(b): What actions must I take if a batch of PET drug product does not conform to specifications?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart H-Finished Drug Product Controls and Acceptance
Key facts
| Citation | 21 CFR 212.71(b) |
|---|---|
| Section | What actions must I take if a batch of PET drug product does not conform to specifications? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart H-Finished Drug Product Controls and Acceptance |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (b) Investigation. You must document the investigation of a PET drug product that does not meet specifications, including the results of the investigation and what happened to the rejected PET drug product. |
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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.