21 CFR 212.20
What activities must I perform to ensure drug quality?
21 CFR 212.20 is the regulation titled “What activities must I perform to ensure drug quality?” in 21 CFR Part 212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 212.30, in 2 letters
- Closed out
- 50% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 212.20 most often, as written in the letters.
- 1 letterYour firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications (21 CFR 212.20(d))
- 1 letterYour firm failed to conduct adequate investigations and take appropriate corrective action when a failure of a production batch or any component of the batch failed to meet any of its specifications. (21 CFR 212.20(d))
The regulation
Read the text of 21 CFR 212.20 (eCFR, as of Sep 1, 2026)
(a) Production operations. You must oversee production operations to ensure that each PET drug meets the requirements of the act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it is supposed to have.
(b) Materials. You must examine and approve or reject components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms to ensure compliance with procedures and specifications affecting the identity, strength, quality, or purity of a PET drug.
(c) Specifications and processes. You must approve or reject, before implementation, any initial specifications, methods, processes, or procedures, and any proposed changes to existing specifications, methods, processes, or procedures, to ensure that they maintain the identity, strength, quality, and purity of a PET drug. You must demonstrate that any change does not adversely affect the identity, strength, quality, or purity of any PET drug.
(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.
(e) Quality assurance. You must establish and follow written quality assurance procedures.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 212.20.
Latest letters citing it
The 2 letters citing 21 CFR 212.20 that FDA posted most recently.
- DrugsView Northland Nuclear Medicine, LLCPET drug manufacturingIssuedOct 22, 2026PostedOct 27, 2026
- DrugsView Brigham and Women’s Hospital Inc.PET drugs including [18F]-Fludeoxyglucose for Injection and [13N]-Ammonia for InjectionIssuedApr 11, 2022PostedMay 10, 2022
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