CFR section
21 CFR 212.20(d): What activities must I perform to ensure drug quality?
PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS · Subpart C-Quality Assurance
Key facts
| Citation | 21 CFR 212.20(d) |
|---|---|
| Section | What activities must I perform to ensure drug quality? |
| Part | PART 212-CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS |
| Subpart | Subpart C-Quality Assurance |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (d) Production records. You must review production records to determine whether errors have occurred. If errors have occurred, or a production batch or any component of the batch fails to meet any of its specifications, you must determine the need for an investigation, conduct investigations when necessary, and take appropriate corrective actions. |
At a glance
- 10–99 Inspections citing this section
- 1–9 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.