21 CFR 212.30
What requirements must my facilities and equipment meet?
21 CFR 212.30 is the regulation titled “What requirements must my facilities and equipment meet?” in 21 CFR Part 212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 212.20, in 2 letters
- Closed out
- 33% 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.
The regulation
Read the text of 21 CFR 212.30 (eCFR, as of Sep 1, 2026)
(a) Facilities. You must provide adequate facilities to ensure the orderly handling of materials and equipment, the prevention of mix-ups, and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
(b) Equipment procedures. You must implement procedures to ensure that all equipment that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained, is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results. You must document your activities in accordance with these procedures.
(c) Equipment construction and maintenance. Equipment must be constructed and maintained so that surfaces that contact components, in-process materials, or PET drugs are not reactive, additive, or absorptive so as to alter the quality of PET drugs.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 212.30.
- 21 CFR 212.20What activities must I perform to ensure drug quality?2 letters cite both
- 21 CFR 207.57What information must registrants submit when updating listing information and when?1 letter cites both
- 21 CFR 212.50What production and process controls must I have?1 letter cites both
- 21 CFR 212.60What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 212.30 that FDA posted most recently.
- DrugsView Northland Nuclear Medicine, LLCPET drug manufacturingIssuedOct 22, 2026PostedOct 27, 2026
- DrugsView 3D Imaging Drug Design and Development LLCPET drugs including Fludeoxyglucose F18IssuedDec 4, 2025PostedDec 16, 2025
- 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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Counts include every citation in a letter, as the Letters filter does. How this database is built.